MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT SIZE2 L

Model Number	02.09.2602L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary surgery on (b)(6) 2021 (competitor knee revised, gmk hinge implanted).Subsequently, on (b)(6) 2021, revision surgery for infection and the pathogen was unknown.The surgeon performed a washout and poly swap.On (b)(6) 2024, revision surgery for infection and the pathogen is unknown.The surgeon revised the femoral component, insert and tibial tray and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03 december 2024: (b)(4) items manufactured and released on 22-mar-2022.Expiration date: 2026-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant revised: gmk-hinge 02.09.0112h fixed tibial insert size 1/12mm (k130299) lot.181567 batch review performed on 03 december 2024: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Gmk-hinge 02.09.4001l fixed tibial tray size 1 l (k130299) lot.2003416 batch review performed on 03 december 2024 (b)(4) items manufactured and released on 09-jun-2020.Expiration date: 2025-06-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FEMORAL COMPONENT SIZE2 L
• 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: 20899856
• Report Number: 3005180920-2024-01069
• Device Sequence Number: 5052503
• Product Code: KRO
• UDI-Device Identifier: 07630030825415
• UDI-Public: 07630030825415
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 03/08/2026
• Device Model Number: 02.09.2602L
• Device Lot Number: 2013195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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