MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR PS SIZE 2 R; KNEE PROSTEHESIS FEMORAL IMPLANT

Model Number	02.07.2402R
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-feb-2021: lot 1900611: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-jun-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs department: 1.25 years after revision knee arthroplasty, the knee becomes unstable because of insufficiency of collateral ligaments.This condition requires a constrained device to be used; the implanted components are therefore removed.It is supposedly due to disease progression and not to a defective device.Another devices involved: batch review performed on 08-feb-2021: gmk-revision 02.07.0212, scf fixed tibial insert sc size 2/12mm (k103170) lot.1904791: (b)(4) items manufactured and released on 22-jul-2019.Expiration date: 2024-jul-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch review performed on 08-feb-2021: gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721)lot.1902918: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-sep-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to lateral and medial instability 1 year and 3 months after the primary surgery.Gmk-revision was replaced with a gmk-hinge.

• Brand Name: GMK-REVISION FEMUR PS SIZE 2 R
• Common Device Name: KNEE PROSTEHESIS FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11307782
• Report Number: 3005180920-2021-00090
• Device Sequence Number: 14296394
• Product Code: JWH
• UDI-Device Identifier: 07630030821394
• UDI-Public: 07630030821394
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 02/10/2021

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: 06/25/2024
• Device Model Number: 02.07.2402R
• Device Catalogue Number: 02.07.2402R
• Device Lot Number: 1900611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR