MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIXED CEMENTED SIZE 4 L

Model Number	02.07.1204L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 february 2025: lot 2242793: (b)(4) items manufactured and released on 02-feb-2023.Expiration date: 2028-jan-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional implants also revised: gmk-sphere 02.12.0005l femoral component sphere cemented size 5 l (k121416) lot.2309761 batch review performed on 17 february 2025 (b)(4) items manufactured and released on 27-jul-2023.Expiration date: 2028-jul-11.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: the reported cause was metal allergy with no alleged device deficiency or contributing factor, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a metal allergy and the cause is unknown.At about 1 year and 4 months post primary the surgeon revised all components to sensitin components and the surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIXED CEMENTED SIZE 4 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: 21524142
• Report Number: 3005180920-2025-00152
• Device Sequence Number: 8455544
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/03/2025

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: 02.07.1204L
• Device Lot Number: 2242793
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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