MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3 L; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2403L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 april 2022: lot 164821: 27 items manufactured and released on 26-sept-2016.Expiration date: 2021-09-13.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-revision 02.07.0312scf fixed tibial insert sc size 3/12mm (k103170) lot.167085.Batch review performed on 11 april 2022: lot 167085: 18 items manufactured and released on 02-feb-2017.Expiration date: 2022-01-12.No anomalies found related to the problem.To date, 13 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-revision 02.07.Fcl12105 extension stem - fluted ø 12 l 105 (k120790) lot.181245.Batch review performed on 11 april 2022: lot 181245: 15 items manufactured and released on 17-may-2018.Expiration date: 2023-05-03.No anomalies found related to the problem.To date, 11 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain and stiffness in the knee and the cause of the pain and stiffness is unknown.At almost 2 years and 10 months after primary the surgeon revised the extension stem, femur, and poly.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14202531
• Report Number: 3005180920-2022-00308
• Device Sequence Number: 19283500
• Product Code: JWH
• UDI-Device Identifier: 07630030821400
• UDI-Public: 07630030821400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 04/26/2022

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: 09/13/2021
• Device Model Number: 02.07.2403L
• Device Catalogue Number: 02.07.2403L
• Device Lot Number: 164821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2016
• 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