MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK HINGE TOTAL KNEE SYSTEM; GMK-HINGE FEMORAL COMPONENT L - SIZE4

Model Number	02.09.2604R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-11-2025.Gmk-hinge 02.09.2604r gmk-hinge femoral component l - size4 (k130299) lot.2418914: (b)(4) items manufactured and released on 11-03-2025 expiration date: 2030-02-19.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 02.09.0310h gmk-hinge tibial insert - size3 - 10 mm (not registered in us) lot.2504321: (b)(4) items manufactured and released on 14-04-2025 expiration date: 2030-03-30.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 02.09.4003r gmk-hinge tibial tray - 3r (k130299) lot.2416007: (b)(4) items manufactured and released on 18-11-2024 expiration date: 2029-10-30.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.Clinical evalutation performed by clinical affairs department: few weeks after revision tka with a constrained device, dislocation occurs.The tibial post jumped out of the insert, and the dislocated post, most probably, pushed the tibial inseert out of its housing on the tibial tray, tearing the screw seating - the safety screw remained in the tibial tray and the insert was dislodged.The only explanation is that the joint was severly unstable in vertical direction: this suspect is reinforced by the fact that in the next surgery the surgeon used a 20mm thick insert instead of the original 10mm.It is also possible that the patient fell, even though he does not recollect the event (but does not exclude it either) and this may have caused an abnormal pull on the tibia that resulted in the extraction of the tibial post from the insert.This event is extremely rare, because it requires a major degree of instability and/or the combination with a traumatic event.The implants do not seem defective.
Event or Problem Description
Revision surgery at 2 months from primary surgery due to dislocation of the post extension and the inlay from the tibial tray.The screw securing the inlay to the tibia was reported to be still fixed to the tibial tray.No issue with the other implants was reported.Torque limiter was used to fix the screw during primary surgery.The joint was very unstable and the surgeon implanted a 20mm insert.Surgery was completed successfully.It was also reported that a traumatic event may have occurred but it was not confirmed.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: a few weeks after revision total knee arthroplasty (tka) with a hinge device, the tibial insert became decoupled from the tibial tray together with hinge post extension.Despite this decoupling, the fixation screw of the insert was reported to remain in place and properly secured to the tibial tray.Inspection of the tibial tray revealed that the hole accommodating the insert screw was damaged and deformed.The pattern of damage is consistent with the screw being forced through the hole as a result of the forces that pushed the liner out of its seating.Visual inspection of the returned components confirmed scratches and deformation indicative of this mechanism.The root cause of the event is considered to be the overall laxity of the joint system, potentially combined with a traumatic event such as a fall.The presence of significant joint laxity is supported by the surgical decision during the revision procedure to implant a thicker liner (20 mm instead of the original 10 mm).Based on the available information, including component inspection and clinical context, there is no evidence to suggest that this event was caused by a defective device.Conclusion: the event may be related to excessive and unexpected loads acting on the system, likely caused by laxity and/or a traumatic event, but this cannot be confirmed with the information available.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 L - SIZE4
• 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: 23669514
• Report Number: 3005180920-2025-01195
• Device Sequence Number: 9881939
• Product Code: KRO
• UDI-Device Identifier: 07630030825460
• UDI-Public: 07630030825460
• Combination Product (Y/N): N
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 02.09.2604R
• Device Lot Number: 2418914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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