MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0705L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months from the primary, the patient came in reporting anterior pain and instability and the cause is unknown.The surgeon revised all components with revision components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 aug 2024.Lot 2304419: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 2028-06-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-sphere 02.12.28t3i4l gmk-sphere tibial tray cemented t3i4l tinbn coated (k202684) lot 2300306: (b)(4) items manufactured and released on 27-jun-2023.Expiration date: 2028-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.E0411fl tibial insert fixed sphere flex #4/11 mm l e-cross (k202022) lot 2307914: (b)(4) items manufactured and released on 19-may-2023.Expiration date: 2028-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 20133229
• Report Number: 3005180920-2024-00690
• Device Sequence Number: 17979522
• Product Code: JWH
• UDI-Device Identifier: 07630040711449
• UDI-Public: 07630040711449
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/04/2024

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 Catalogue Number: 02.12.0705L
• Device Lot Number: 2304419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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: Female