MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; GMK-REVISION 02.07.0317SCF FIXED TIBIAL INSERT SC SIZE 3/17MM

Model Number	02.07.0317SCF
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
About 3 years and 7 months after the primary surgery, the support peg is unscrewed.The patient complains about instability and pain.Revision surgery performed 3 years and 8 months after the primary surgery.Only the inlay and peg revised (with 20mm inlay).Torque limiter 6nm used at the primary surgery.
Additional Manufacturer Narrative
Batch review performed on 22 may 2025.Lot 172163: (b)(4) items manufactured and released on 24/05/2017.Expiration date: 09/05/2022.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.Other device involved: gmk-revision 02.07.0683r revision fixed tibial tray cemented size 3 r (k123721) lot.2008683: (b)(4) items manufactured and released on 18/12/2020.Expiration date: 06/12/2025.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.A conclusion has yet to be established as the investigation is incomplete.
Additional Manufacturer Narrative
Reason for follow-up: devices received on 14 july 2025.Information entered: the torque limiter used during the primary surgery was received and analyzed visual inspection of the explanted components clinical evaluation conclusions.Inspection of the explanted devices and the torque limiter used during the primary surgery.About 3 years and 8 months following revision total knee arthroplasty (rtka), the support peg of the tibial insert was found to be unscrewed.The primary function of the support peg[?]once correctly threaded into the tibial tray[?]is to enhance the rigidity of the posterior-stabilized (ps) cam mechanism.If the peg becomes unscrewed, this function is compromised.Despite the peg being found unscrewed, the insert itself appeared to remain in place, with no signs of construct dislocation.The patient reported a sensation of instability, which could plausibly be related to the ineffective support of the cam.However, other contributing factors such as progressive soft tissue laxity cannot be ruled out.Inspection of the explanted sc peg confirmed that it conformed to specifications.The torque limiter was also received and inspected and found to be conforming.The root cause of the event remains undetermined.Possible contributing factors include insufficient tightening during surgery or improper use of the torque-limiting screwdriver.Based on all available evidence to date, there is no indication of a manufacturing defect.Clinical evaluation about 3 years and 8 months after revision tka, the metal threaded peg that gives rigidity to the central post of the tibial insert is progressively self-unscrewing.This will possibly lead to instability of the insert.The lamented instability of the knee to date may not be related to the self-unscrewing; indeed, it is very likely that it isn't.The self-unscrewing of this peg, which should be tightened at 6nm, with a torque-limiter screwdriver to determine the correct tightening torque, is a very rare event, so we could not establish any possible cause yet.As is normal for screwed couplings, a possible cause is insufficient tightening torque.According to the report, the torque-limiting screwdriver was used during index surgery, so the two most likely explanations are that the torque-limiting mechanism was defective or that the torque limit was not reached.However, the torque limiter used at the primary surgery has been inspected and found to be conforming.The root cause of the event remains undetermined.There is no indication of any device-related root cause.Conclusions: a possible cause for this event could be insufficient torque applied at index surgery.However, no determination can be made based on the information available.There is no evidence suggesting a manufacturing defect, and the product's performance history does not indicate any systemic issue related to the design or quality of production.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: GMK-REVISION 02.07.0317SCF FIXED TIBIAL INSERT SC SIZE 3/17MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22194900
• Report Number: 3005180920-2025-00527
• Device Sequence Number: 21129467
• Product Code: JWH
• UDI-Device Identifier: 07630030817410
• UDI-Public: 07630030817410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Expiration Date: 05/09/2022
• Device Model Number: 02.07.0317SCF
• Device Lot Number: 172163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• 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: Unknown