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

Catalog Number 02.12.KA13L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 12/28/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 332974916
• Report Number: 3005180920-2023-01097
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630345716217
• UDI-Public: 07630345716217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.12.KA13L
• Device Lot Number: 2303087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female