MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S4+R CEMENTED

Model Number	02.12.KA14R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year from the primary, the patient came in due to a loose femoral implant and the cause is unknown.The surgeon noted that the bone quality was good and there were no signs of infection.Additionally, there was no reported trauma.The surgeon revised the medacta tibial tray, insert, and femoral component to a competitor tray, insert, and femoral component.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 february 2026.Gmk-spherika 02.12.Ka14r gmk spherika femoral component s4+r cemented (k211004) lot 2402430: (b)(4) items manufactured and released on 09-jun-2024.Expiration date: 25-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: aseptic loosening 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.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S4+R CEMENTED
• 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: 24494900
• Report Number: 3005180920-2026-00190
• Device Sequence Number: 4953936
• Product Code: JWH
• UDI-Device Identifier: 07630345716248
• UDI-Public: 07630345716248
• Combination Product (Y/N): N
• PMA/510(K) Number: K211004
• 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): 03/03/2026

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.KA14R
• Device Lot Number: 2402430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2024
• 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: Unknown