MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 2

Model Number	02.07.1202L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 months after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and implanted new permanent products.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11-11-2024.Lot 2313903: (b)(4) items manufactured and released on 13-09-2023.Expiration date: 2028-08-22.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.Additiona implants revised, batch review performed on 11-11-2024.Gmk-sphere 02.12.0003l gmk-sphere femoral component cemented - 3l (k121416) lot 2307454: (b)(4) items manufactured and released on 27-06-2023.Expiration date: 2028-06-06.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.Gmk-sphere 02.12.E0220fl gmk-sphere tibial insert e-cross - flex 2l - 20mm (k202022) lot 2243352: (b)(4) items manufactured and released on 24-01-2023.Expiration date: 2028-01-04.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold.Gmk-sphere 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3 (k202022) lot 2314690: (b)(4) items manufactured and released on 16-10-2023.Expiration date: 2028-09-26.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold with no similar reported event during the period of review.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 PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL TRAY CEMENTED LEFT, SIZE 2
• 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: 20732325
• Report Number: 3005180920-2024-00974
• Device Sequence Number: 18373338
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• 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: 2024
• 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): 11/20/2024

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 Model Number: 02.07.1202L
• Device Lot Number: 2313903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2023
• 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: Female