MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0411CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/11 MM L; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0411CRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 november 2023.Lot 2104788: (b)(4) manufactured and released on 06-jul-2021.Expiration date: 2026-06-22.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 6 months from the primary, the patient came in reporting instability due to laxity and the cause is unknown.The surgeon revised the liner (from 11 mm to 14mm) and the surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0411CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/11 MM L
• Common Device Name: KNEE TIBIAL INSERT FIXED
• 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: 18245852
• Report Number: 3005180920-2023-00925
• Device Sequence Number: 17813840
• Product Code: JWH
• UDI-Device Identifier: 07630040707497
• UDI-Public: 07630040707497
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• 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): 12/01/2023

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 Expiration Date: 06/22/2026
• Device Catalogue Number: 02.12.0411CRL
• Device Lot Number: 2104788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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