MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED; KNEE CEMENTED FEMUR

Catalog Number	02.12.KA13L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-jan-2024: lot 2303087: 35 items manufactured and released on 27-apr-2023.Expiration date: 2028-04-10.No anomalies found related to the problem.To date, 23 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved.Batch reviews performed on 16-jan-2024: gmk-spherika 02.12.T4i3l gmk-sphere tibial component cemented t4i3l (k121416) lot 2012087: 57 items manufactured and released on 12-apr-2021.Expiration date: 2026-03-26.No anomalies found related to the problem.To date, 46 items of the same lot have been sold without any similar reported event during the period of review.Gmk-spherika 02.12.T4i3l gmk-sphere tibial component cemented t4i3l (k121416) lot 2012087: 57 items manufactured and released on 12-apr-2021.Expiration date: 2026-03-26.No anomalies found related to the problem.To date, 46 items of the same lot have been sold without any similar reported event during the period of review.Gmk-spherika 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3 (k202022) lot 2311197: 110 items manufactured and released on 05-sep-2023.Expiration date: 2028-08-21.No anomalies found related to the problem.To date, 70 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
A day after the primary knee surgery, the patient reported instability and the cause is unknown.The surgeon decided to revise the patient to gmk-hinge components.The surgery was completed successfully.

• Brand Name: GMK-SPHERIKA GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 18524338
• Report Number: 3005180920-2023-01097
• Device Sequence Number: 8125760
• Product Code: JWH
• UDI-Device Identifier: 07630345716217
• UDI-Public: 07630345716217
• 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): 01/17/2024

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.KA13L
• Device Lot Number: 2303087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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