MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 3 E-CROSS; KNEE PATELLA BUTTON

Catalog Number	02.12.E003RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 months after primary, the patient came in reporting pain due to a ruptured patella tendon and the cause is unknown.The surgeon performed patella tendon repair and revised all components to hinge components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-jul-2024.Gmk-sphere 02.12.E003rp patella resurfacing size 3 e-crosslot 2311197: 110 items manufactured and released on 05-sep-2023.Expiration date: 2028-08-21.No anomalies found related to the problem.To date, 89 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved in the event: batch review performed on 16-jul-2024.Gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l lot 2307467: 107 items manufactured and released on 06-jul-2023.Expiration date: 2028-06-12.No anomalies found related to the problem.To date, 88 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 16-jul-2024.Gmk-sphere 02.12.E0513fl tibial insert fixed sphere flex size 5/13 mm l e-cross lot 2119158: 25 items manufactured and released on 03-mar-2022.Expiration date: 2027-02-20.No anomalies found related to the problem.To date, 10 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 16-jul-2024.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l lot 2305877: 24 items manufactured and released on 27-jun-2023.Expiration date: 2028-06-10.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 3 E-CROSS
• Common Device Name: KNEE PATELLA BUTTON
• 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: 19749118
• Report Number: 3005180920-2024-00527
• Device Sequence Number: 15081501
• Product Code: JWH
• UDI-Device Identifier: 07630971260993
• UDI-Public: 07630971260993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 07/16/2024

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.E003RP
• Device Lot Number: 2311197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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: Unknown