MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; GMK SPHERIKA FEMORAL COMPONENT S5R CEMENTED

Model Number	02.12.KA05R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had knee infection and the pathogen is unknown.At about 2 months post primary surgery the surgeon performed a washout and revised the femoral component, insert, and tibial tray inserting antibiotic spacers.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch reviews performed on 10 july 2026: gmk-spherika 02.12.Ka05r gmk spherika femoral component s5r cemented (k211004) lot 2533842: (b)(4) items manufactured and released on 11-mar-2026.Expiration date: 26-feb-2031.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 02.12.E0511fr gmk-sphere tibial insert e-cross - flex 5r - 11mm (k202022) lot 2521360: (b)(4) items manufactured and released on 02-oct-2025.Expiration date: 14-sep-2030.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 gmk tibial tray cemented right s5 (k090988) lot 2524831: (b)(4) items manufactured and released on 01-apr-2026.Expiration date: 16-mar-2031.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: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S5R 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: 25838710
• Report Number: 3005180920-2026-00720
• Device Sequence Number: 9759959
• Product Code: JWH
• UDI-Device Identifier: 07630345716125
• UDI-Public: 07630345716125
• Combination Product (Y/N): N
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/16/2026

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.KA05R
• Device Lot Number: 2533842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2026
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 108 KG