MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN JOURNEY BCS / JOURNEY II BCS KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Summary report quarter: january 1, 2024, through march 31, 2024.B3: actual date of event(s) is unknown.Date range for registry report includes all events from 2007 through 31 december 2021.G3: this report is being submitted as part of a retrospective review of previously downloaded registry data that was assessed for adverse event reporting on 25 april 2024.H3, h6: it was reported that from the registry study "online lroi annual report 2022", 64 patients underwent a revision surgery due to unspecified reasons after a primary tka with a journey ii bcs tka system.Patients' outcomes are unknown.No further information is available.Joint arthroplasty data ranges from 2007 to 31 december 2021.This complaint was opened by smith+nephew to document a patient complication identified through a review of the "online lroi annual report 2022" from the netherlands that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporter¿s device.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

Event Description

It was reported that from the registry study "online lroi annual report 2022", 64 patients underwent a revision surgery due to unspecified reasons after a primary tka with a journey ii bcs tka system.Patients' outcomes are unknown.No further information is available.Joint arthroplasty data ranges from 2007 to 31 december 2021.

Manufacturer Narrative

Exemption number was included.

Event Description

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0
CASE-2024-00206716-1,UNKNOWN,4/30/2024,9/12/2023,JOURNEY II BCS,JOURNEY II BCS,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,No,IN,"It was reported that from the registry study ""Online LROI annual report 2022"", 1 patient underwent a revision surgery due to unspecified reasons after a primary TKA with a Journey II BCS TKA System. Patients' outcomes are unknown. No further information is available. ","This complaint was opened by Smith+Nephew to document a patient complication identified through a review of the ""Online LROI annual report 2022"" from The Netherlands that includes reference to the use of a Smith+Nephew product. The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. Smith+Nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture. The limited nature of registry data coupled with the anonymity of contributing healthcare providers prohibits further follow-up to obtain additional event and patient information or return of the reporterâ¿¿s device. Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause. However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations. If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required. ",,66,UNKNOWN,UNKNOWN,UNKNOWN,UNKNOWN,E2401,F1901; F1905,A24,G07001,B20; B22,C19,D12; D15,N/A,0

• Brand Name: UNKN JOURNEY BCS / JOURNEY II BCS KNEE
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19217407
• MDR Text Key: 341458120
• Report Number: 1020279-2024-00855
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 64
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR