MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S3

Model Number	02.12.E003RP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 january 2026.Gmk-spherika 02.12.E003rp gmk-sphere resurfacing patella e-cross - s3 (k202022) lot 2411322: (b)(4) items manufactured and released on 05-jul-2024.Expiration date: 06-jun-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: dislocation is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 11 months from the primary, the patient came in due pain as a result of chronic dislocation of the patella and the cause is unknown.Previous dislocations corrected with reduction.The surgeon revised the femur, tibial component, and insert from gmk-spherika to gmk-revision to address the dislocations.The surgery was completed successfully.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE RESURFACING PATELLA E-CROSS ¿ S3
• 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: 24399531
• Report Number: 3005180920-2026-00121
• Device Sequence Number: 12801611
• Product Code: JWH
• UDI-Device Identifier: 07630971260993
• UDI-Public: 07630971260993
• 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): 02/20/2026

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.E003RP
• Device Lot Number: 2411322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2024
• 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