MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT R - SIZE5

Model Number	02.09.2605R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to a fractured femur after about 2 months from primary and the cause is unknown.The was no indication of trauma, but the surgeon did note poor bone quality.The surgeon revised gmk-hinge size 5 femoral component to a same size femoral component and revised the gmk-hinge 12mm insert to a gmk-hinge 14mm insert due to laxity.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 may 2026 gmk-hinge 02.09.2605r gmk-hinge femoral component r - size5 (k130299) lot.2315255: (b)(4) items manufactured and released on 16-oct-2023.Expiration date: 2028-sep-16.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-hinge 02.09.0612h gmk-hinge tibial insert - size6 - 12 mm (k130299) lot.2215600: (b)(4) items manufactured and released on 18-aug-2022.Expiration date: 2027-jul-24.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: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK HINGE TOTAL KNEE SYSTEM
• Common Device Name: GMK-HINGE FEMORAL COMPONENT R - SIZE5
• 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: 25160348
• Report Number: 3005180920-2026-00444
• Device Sequence Number: 10716908
• Product Code: KRO
• UDI-Device Identifier: 07630030825484
• UDI-Public: 07630030825484
• Combination Product (Y/N): N
• PMA/510(K) Number: K130299
• 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): 05/13/2026

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: 02.09.2605R
• Device Lot Number: 2315255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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 Sex: Male