MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L; KNEE CEMENTED TIBIAL INSERT

Model Number	02.12.0414FL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months after the primary, the patient came in reporting instability and difficulty ambulating and the cause is unknown.The surgeon revised the patient's poly on the left and right knee.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 november 2022: lot 2112465: 75 items manufactured and released on 15-nov-2021.Expiration date: 2026-11-02.No anomalies found related to the problem.To date, 22 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved: batch review performed on 31 october 2022: gmk-sphere 02.12.0414fr tibial insert fixed sphere flex size 4/14 mm r (k121416) lot 2011402: 25 items manufactured and released on 17-feb-2021.Expiration date: 2026-02-08.No anomalies found related to the problem.To date, 6 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
• Common Device Name: KNEE CEMENTED 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: 15778446
• Report Number: 3005180920-2022-00863
• Device Sequence Number: 6657273
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• 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): 11/11/2022

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 Model Number: 02.12.0414FL
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 2112465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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