MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN COCR CONSTRAINED FEM 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Model Number 71425005

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Type  Injury  

Event Description

It was reported that, the patient underwent a left tka revision due to joint stiffness as primary diagnosis.Approximately thirty two (32) months after this procedure, the patient experienced aseptic loosening 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.

Manufacturer Narrative

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.(b)(4).

• Brand Name: LGN COCR CONSTRAINED FEM 5 LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY
• 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: 16218882
• MDR Text Key: 307838921
• Report Number: 1020279-2023-00157
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010580337
• UDI-Public: 03596010580337
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71425005
• Device Catalogue Number: 71425005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2023
• 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: 71424003/LGN REV TIBIA BASE SZ 3 LT
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female