MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ7-8 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71426008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the patient underwent a right tka revision due to aseptic loosening as primary diagnosis with bearing wear and patella maltracking or instability as secondary diagnoses.Approximately ninety eight (98) months after this procedure, the patient experienced instability of the revised knee prosthesis and required a second revision.The dates in which the index surgery, first revision and second revision took place are not known.It is also unknown which devices were explanted and/or exchanged during the second revision.This incident was identified in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing tka revision outcomes were gathered; therefore, additional information is not known.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities 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.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 or Problem Description
It was reported that, the patient underwent a right tka revision in 2008 due to aseptic loosening as primary diagnosis with bearing wear and patella maltracking or instability as secondary diagnoses.Approximately ninety eight (98) months after this procedure, the patient experienced instability of the revised knee prosthesis and required a second revision.During the second revision, the genesis ii constrained art insert size 7-8 18mm was explanted and exchanged.This incident was identified in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing tka revision outcomes were gathered; therefore, additional information is not known.
Additional Manufacturer Narrative
Additional information: d4 (expiration date), h4 (manufacturing date).Corrected data: b5 (narrative), d1 (brand name), d4 (catalog number, udi number, lot number), d10 (concomitants added), g4 (510k).

• Brand Name: GNS II CON INS SZ7-8 18MM
• Common Device Name: 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: 16216023
• Report Number: 1020279-2023-00153
• Device Sequence Number: 5924959
• Product Code: JWH
• UDI-Device Identifier: 03596010208217
• UDI-Public: 3596010208217
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2015
• Device Model Number: 71426008
• Device Catalogue Number: 71420558
• Device Lot Number: 05MM02612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 09/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71420578 / LOT: 04CM07342.; PN: 71420578 / LOT: UNKNOWN.; PN: 71421771 / LOT: 07CM05694.; PN: 71424017 / LOT: 08BM21924.; PN: 71424017 / LOT: UNKNOWN.; PN: 71424037 / LOT: 06EAB0036.; PN: 71424051 / LOT: 07LAB0020D.; PN: 71424223 / LOT: 07JM11703.; PN: 71424225 / LOT: 07JM04185.; PN: 71426008 / LOT: 07LM14416.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 147 KG