MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.E0312CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/12 MM L; KNEE TIBIAL INSERT FIXED

Model Number	02.12.E0312CRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause is unknown.At about 1 month post primary the surgeon revised the insert (12 to 14 mm) and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 23 january 2023: lot 2116990: (b)(4) items manufactured and released on 20-jan-2022.Expiration date: 2026-12-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE 02.12.E0312CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/12 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16385150
• Report Number: 3005180920-2023-00057
• Device Sequence Number: 12160722
• Product Code: JWH
• UDI-Device Identifier: 07630971261570
• UDI-Public: 07630971261570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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 Model Number: 02.12.E0312CRL
• Device Catalogue Number: 02.12.E0312CRL
• Device Lot Number: 2116990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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