MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0314FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0314FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 december 2022.Lot 2005743: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 2025-aug-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with (b)(4) similar reported events during the period of review.
Event or Problem Description
The patient came in reporting instability due to laxity.At 2 months and a half, the surgeon revised the 14mm poly with a 20mm poly, and the surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0314FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L
• Common Device Name: KNEE TIBIAL INSERT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16067302
• Report Number: 3005180920-2022-00985
• Device Sequence Number: 13964346
• Product Code: JWH
• UDI-Device Identifier: 07630030826412
• UDI-Public: 07630030826412
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/29/2022

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: 08/20/2025
• Device Model Number: 02.12.0314FL
• Device Catalogue Number: 02.12.0314FL
• Device Lot Number: 2005743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2020
• 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 Age: 58 YR
• Patient Sex: Female