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

Model Number	02.12.0417FR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-jun-2022.Lot 2002798: (b)(4) items manufactured and released on 13-may-2020.Expiration date: 2025-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in reporting instability due to laxity and the cause was unknown.The surgeon revised the gmk-sphere tibial insert with a thicker one to give the patient more stability.The surgery was completed successfully.Presently, (b)(6) 2022, the patient came in reporting instability due to laxity.The surgeon revised gmk-sphere tibial insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19-aug-2022.Lot 2001705: (b)(4) items manufactured and released on 31-mar-2020.Expiration date: 2025-03-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
The patient came in for a revision right knee surgery and primary left knee surgery on (b)(6) 2021.On (b)(6) 2022, the patient came in reporting instability due to laxity.The surgeon revised gmk-sphere tibial insert - flex left - 11 mm s4 with a gmk-sphere tibial insert - flex s4l - 17mm.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
• Common Device Name: KNEE TIBIAL INSERT PE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15027950
• Report Number: 3005180920-2022-00526
• Device Sequence Number: 12010665
• Product Code: JWH
• UDI-Device Identifier: 07630030862601
• UDI-Public: 07630030862601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 03/16/2025
• Device Model Number: 02.12.0417FR
• Device Catalogue Number: 02.12.0411FL
• Device Lot Number: 2001705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2020
• 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: Male