MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0512FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-mar-2024.Lot 2005772: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-09-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 other similar reported events during the period of review.
Event or Problem Description
At about 3 months after primary, the patient came in reporting instability and the cause is unknown.The surgeon revised the insert (12mm) with a thicker one (13mm) and the surgery was completed successfully.

• Brand Name: GMK-SPHERIKA 02.12.0512FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R
• 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: 19097062
• Report Number: 3005180920-2024-00198
• Device Sequence Number: 7813015
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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 Expiration Date: 09/03/2025
• Device Catalogue Number: 02.12.0512FR
• Device Lot Number: 2005772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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