MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT PS FIXED 10MM, SIZE 4

Model Number	02.07.0410PSF
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2025: lot 132304: (b)(4) items manufactured and released on 05/08/2013.Expiration date: 30/06/2018.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 evaluation performed by clinical affairs department: about 12 years after primary cemented tka, the insert safety screw is found unscrewed at a routine xray check.The surgeon therefore revised the insert, while the metal components were satisfactorily stable and working.No other damage has been reported or should be expected.Spontaneous screw back-out has been reported previously, and was commonly associated with insufficient tightening torque administered at the time of index surgery.Since the introduction of the torque limiting screwdriver, the number of observations, which was already less than 0.1% of the cases, almost zeroed.However, backing off after such a long time in situ is very rare, though we do not know when the event actually took place.Root cause: the most likely reason for this event is insufficient torque applied to the screw at index surgery.However, other factors may also have played a role, but no determination can be made based.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
The patient came in for a post-op appointment and it was observed that the screw from the poly was floating in the knee.It is unknown how this occurred.About 11 years and 9 months after the primary surgery, the surgeon revised the liner and the surgery was completed successfully.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT PS FIXED 10MM, SIZE 4
• 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: 22394391
• Report Number: 3005180920-2025-00627
• Device Sequence Number: 15743292
• Product Code: JWH
• UDI-Device Identifier: 07630030817649
• UDI-Public: 07630030817649
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: 06/30/2018
• Device Model Number: 02.07.0410PSF
• Device Lot Number: 132304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2013
• 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: Female