MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S4

Model Number	02.12.E004RP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 12 june 2026: gmk-sphere 02.12.E004rp gmk-sphere resurfacing patella e-cross - s4 (k202022) lot 2402490: (b)(4) items manufactured and released on 02-apr-2024.Expiration date: 19-mar-2029.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.E0511fl gmk-sphere tibial insert e-cross - flex 5l - 11mm (k202022) lot 2402557: (b)(4) items manufactured and released on 13-mar-2024.Expiration date: 27-feb-2029.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.Root cause: the surgeon revised liner and patella implant to restore the joint stiffness.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
The patient had knee instability and the cause is unknown.Additionally, the surgeon observed a patella bone fragment floating in the knee which was removed.The cause is unknown.There was no indications of trauma.At about 1 year and 5 months post primary the surgeon revised the s4 resurfacing patella to a s3 patella, and revised the 11mm flex 5l insert to a 13mm flex 5l insert.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S4
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25632993
• Report Number: 3005180920-2026-00605
• Device Sequence Number: 13099712
• Product Code: JWH
• UDI-Device Identifier: 07630971261006
• UDI-Public: 07630971261006
• Combination Product (Y/N): N
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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.E004RP
• Device Lot Number: 2402490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2024
• 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 Age: 48 YR
• Patient Sex: Male