MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0317SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had stiffness in the knee and the cause is unknown.At about 2 years and 11 months post primary the surgeon revised the semiconstrained liner and implanted a postero-stabilized liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2024.Lot 2001349: 18 items manufactured and released on 24-mar-2020.Expiration date: 2025-03-11.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18901162
• Report Number: 3005180920-2024-00121
• Device Sequence Number: 7886732
• Product Code: JWH
• UDI-Device Identifier: 07630030817410
• UDI-Public: 07630030817410
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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: 03/11/2025
• Device Catalogue Number: 02.07.0317SCF
• Device Lot Number: 2001349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown