MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S5+R CEMENTED

Model Number	02.12.KA15R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 2 months from the primary, the patient came in presenting pain and signs of metal allergy.The surgeon performed a washout and revised the gmk-spherika s5+r cemented femoral component to a gmk-hinge femoral component size5 r - tinbn coated, revised the flex 5r - 10mm insert to a size5 - 14 mm gmk-hinge insert, and revised the cemented right s5 tibial tray to a gmk-hinge fixed tinbn coated tibial tray - 5r.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 june 2026 gmk-spherika 02.12.Ka15r gmk spherika femoral component s5+r cemented (k211004) lot 2422163: (b)(4) items manufactured and released on 30-oct-2024.Expiration date: 17-oct-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-spherika 02.07.1205r tibial tray fix cemented s.5r (k090988) lot 2420949: (b)(4) items manufactured and released on 13-jan-2025.Expiration date: 08-dec-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 reported cause was metal allergy with no alleged device deficiency involved, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S5+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: 25677108
• Report Number: 3005180920-2026-00603
• Device Sequence Number: 4671375
• Product Code: JWH
• UDI-Device Identifier: 07630345716262
• UDI-Public: 07630345716262
• 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): 07/01/2026

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.KA15R
• Device Lot Number: 2422163
• 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: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2024
• 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: 61 YR
• Patient Sex: Male