MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R; KNEE FEMUR

Model Number	02.07.2404R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in reporting pain due to a loose femur and the cause of the loose femur is unknown.The surgeon revised the femoral component and poly.The surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting instability and the cause is unknown.The surgeon revised all components to competitor components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18-aug-2022.Lot 2009725: (b)(4) items manufactured and released on 05-mar-2021.Expiration date: 2026-02-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: batch review performed on 18-aug-2022: gmk-revision 02.07.0420scf fixed tibial insert sc size 4/20mm (k103170) lot.178515 lot 178515: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-apr-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-revision 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 2005040: (b)(4) items manufactured and released on 21-sep-2020.Expiration date: 2025-sep-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-revision 02.07.0035rp patella resurfacing size 3 (k090988) lot 2008650: (b)(4) items manufactured and released on 30-sep-2020.Expiration date: 2025-sep-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-revision 02.07.Fcl16065 extension stem - fluted ø 16 l 65 (k120790) lot 1904822: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-nov-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: GMK-REVISION 02.07.2404R FEMUR REVISION PS SIZE 4 R
• Common Device Name: KNEE FEMUR
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15392106
• Report Number: 3005180920-2022-00678
• Device Sequence Number: 5007142
• Product Code: JWH
• UDI-Device Identifier: 07630030821431
• UDI-Public: 07630030821431
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: 02/23/2026
• Device Model Number: 02.07.2404R
• Device Catalogue Number: 02.07.2404R
• Device Lot Number: 2009725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2017
• 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: Female