MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED

Model Number	02.12.KA13L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 22 december 2025: gmk-spherika 02.12.Ka13l gmk spherika femoral component s3+l cemented (k211004) lot 2313303: (b)(4) items manufactured and released on 10-oct-2023.Expiration date: 2028-jul-10.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-spherika 02.07.1203l tibial tray fix cemented s.3l (k090988) lot 2314534: (b)(4) items manufactured and released on 13-sep-2023.Expiration date: 2028-aug-24.No anomalies found related to the problem.To date, all the 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.
Event or Problem Description
The patient had knee instability due to loose implants and the cause is unknown.The surgeon suspected a nickel allergy and at about 1 year and 10 months post primary revised the tibial tray and femoral component to sensitin revision components.The surgeon also revised the insert from a 10mm to a 12mm.The surgery was completed successfully.
Event or Problem Description
The patient had knee instability due to loose tibial tray and the cause is unknown.The patient self-reported nickel sensitivity to the surgeon in the pre-op meeting.At about 1 year and 10 months post primary revised all the implants and inserted sensitin revision components.The surgeon also revised the insert from a 10mm to a 12mm.The surgery was completed successfully.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S3+L CEMENTED
• 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: 24051152
• Report Number: 3005180920-2026-00012
• Device Sequence Number: 18605699
• Product Code: JWH
• UDI-Device Identifier: 07630345716217
• UDI-Public: 07630345716217
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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.KA13L
• Device Lot Number: 2313303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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 Age: 62 YR
• Patient Sex: Female