MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT PS FIXED SIZE 1/20MM

Model Number	02.07.0120PSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 may 2025 (b)(4) items manufactured and released on 12-july-2022.Expiration date: 2027-07-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Additional devices involved: gmk-revision 02.07.Fsc11065 extension stem - cemented ø 11 l 65 (k120790) lot.2419562 (b)(4) items manufactured and released on 30-oct-2024.Expiration date: 2029-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-revision 02.07.4681l tinbn coated revision tibial tray size 1 left (k210010) lot.Unknown gmk-primary unknown femur implant.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery due to knee instability of the collaterals.The surgeon revised all system with a gmk hinge.Primary surgery unknown.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT PS FIXED SIZE 1/20MM
• 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: 22060632
• Report Number: 3005180920-2025-00463
• Device Sequence Number: 12671058
• Product Code: JWH
• UDI-Device Identifier: 07630030816321
• UDI-Public: 07630030816321
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/21/2025

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 Model Number: 02.07.0120PSF
• Device Lot Number: 2209252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White