MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA FEMORAL COMPONENT S7L CEMENTED; KNEE FEMORAL COMPONENT

Catalog Number	02.12.KA07L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and explanted the femoral component, tibial tray and insert.The surgeon implanted temporary spacers as part of the 2-stage infection protocol.The surgery was completed successfully.Permanent implants will be implanted at a later date.
Additional Manufacturer Narrative
Batch review performed on 10 january 2024.Lot 2245852: 13 items manufactured and released on 07-march-2023.Expiration date: 2028-02-16.No anomalies found related to the problem.To date, 4 items of the same lot have been sold without any similar reported event during the period of review.Additional implants involved, batch review performed on 10 january 2024: gmk-spherika 02.12.E0513fl gmk-sphere tibial insert e-cross - flex 5l - 13mm (k202022) lot.2208416: 25 items manufactured and released on 26-july-2022.Expiration date: 2027-07-06.No anomalies found related to the problem.To date, 6 items of the same lot have been sold without any similar reported event during the period of review.Gmk-spherika 02.07.1205l tibial tray fix cemented s.5l (k090988) lot.2301592: 48 items manufactured and released on 24-may-2023.Expiration date: 2028-05-08.No anomalies found related to the problem.To date, 44 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERIKA FEMORAL COMPONENT S7L CEMENTED
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 18484051
• Report Number: 3005180920-2023-01095
• Device Sequence Number: 19519610
• Product Code: JWH
• UDI-Device Identifier: 07630345716156
• UDI-Public: 07630345716156
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/10/2024

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 Catalogue Number: 02.12.KA07L
• Device Lot Number: 2245852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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: Male