MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12 MM

Model Number	02.12.0512FR
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 3 year and 4 months due to infection, and the pathogen is unknown.The surgeon revised the gmk-sphere tray, femur, and insert to gmk-revision, and revised the patient`s natural patella.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16 mar 2026 gmk-sphere 02.12.0512fr gmk-sphere tibial insert - flex s5r - 12 mm (k121416) lot.2104758: (b)(4) items manufactured and released on 18 june 2021.Expiration date: 03 june 2026.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-sphere 02.07.1205r tibial tray fix cemented s.5r (k090988) lot.2119254: (b)(4) items manufactured and released on 26 apr 2022.Expiration date: 10 april 2027.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0005r gmk-sphere femoral component cemented - 5r (k121416) lot.2116066: (b)(4) items manufactured and released on 19 jan 2022.Expiration date:10 jan 2027.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 SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE TIBIAL INSERT - FLEX S5R - 12 MM
• 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: 24603546
• Report Number: 3005180920-2026-00223
• Device Sequence Number: 8366599
• Product Code: JWH
• UDI-Device Identifier: 07630030826788
• UDI-Public: 07630030826788
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/16/2026

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 Expiration Date: 06/03/2026
• Device Model Number: 02.12.0512FR
• Device Lot Number: 2104758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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: Male