MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE RESURFACING PATELLA E-CROSS - S1

Model Number	02.12.E001RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 months from primary, the patient came in reporting pain due to a torn patella tendon and the cause is unknown.The surgeon revised the patella and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28-august-2025: lot: 2401812: (b)(4) items manufactured and released on 22-03-2024 expiration date: 2029-03-11.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.Revision surgery was performed to repair the torn patellar tendon; there is no reason to suspect a faulty device.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS - S1
• 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: 23070843
• Report Number: 3005180920-2025-00869
• Device Sequence Number: 11923523
• Product Code: JWH
• UDI-Device Identifier: 07630971260979
• UDI-Public: 07630971260979
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

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.E001RP
• Device Lot Number: 2401812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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
• Patient Race: White