MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4R

Model Number	02.12.0004R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed 2 years and 4 months after the primary procedure due to a nickel allergy, which resulted in joint stiffness.The surgeon revised the gmk sphere femoral component, tray, and insert with tinbn-coated components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 jan 2026.Gmk-sphere 02.12.0004r gmk-sphere femoral component cemented - 4r (k121416) lot.2216424: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-sept-28.One confirmed anomaly was recorded for this lot; no trend or additional issues were identified.To date, (b)(4) items of the same lot have been sold during the period of review.Gmk-sphere 02.12.T3i4r gmk-sphere tibial component cemented t3i4r (k121416) lot: 2308908: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 2028-july-05.One confirmed anomaly was reported for this lot; no additional anomalies or trends were identified.To date, (b)(4) items of the same lot have been sold during the period of review.Root cause:based on the available information, no definitive root cause can be established.However, the clinical and radiographic findings are consistent with a local allergic reaction.There is no indication that a device-related issue caused or contributed to the event, and the device history record review did not identify any manufacturing-related issues.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4R
• 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: 24321117
• Report Number: 3005180920-2026-00098
• Device Sequence Number: 13220626
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/12/2026

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: 02.12.0004R
• Device Lot Number: 2216424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White