MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UK TIB INSRT MED SZ 5-6 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74026170

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

Patient Problem Insufficient Information (4580)

Event Date 12/27/2020

Event Type  Injury  

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 Description

It was reported that, after a right medial unicompartmental knee replacement had been performed on (b)(6) 2019 to address a medial gonarthrosis symptoms, the patient required a revision surgery on (b)(6) 2020 due to unspecified complications and/or adverse events where the tibial insert was exchanged.The outcome of this patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered retrospectively; therefore, additional information is not known.

• Brand Name: JOURNEY II UK TIB INSRT MED SZ 5-6 10MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 16550228
• MDR Text Key: 311370068
• Report Number: 1020279-2023-00547
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556677155
• UDI-Public: 00885556677155
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2023

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: Health Professional
• Device Model Number: 74026170
• Device Catalogue Number: 74026170
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/15/2023
• 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
• Treatment: JOURNEY II UK MED TIB BASE SZ 5 RT.; JOURNEY II UK OX FEM SZ 6 RM/LL.
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male