MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL INSERT PS FIXED SIZE 2/12MM; KNEE FIXED TIBIAL INSERT

Model Number	02.07.0212PSF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022, lot 168560: 30 items manufactured and released on (b)(6) 2017.Expiration date: (b)(6) 2022.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director at 2 years after a complex revision tka surgery, a traumatic event occurs that reportedly determined the fracture of the insert fixation screw and partial dislocation of the insert.The report does not specify if a new screw could be implanted, and no post-revision xrays are supplied.It is conceivable that no screw could be used for the second revision.It must be noted that the original insert was of low thickness (12mm), there is no information as to the thickness of the new insert used.The lower the insert, the more stable it can be expected to be, even in absence of the fixation screw.Given the complex situation of the involved joint, removal/substitution of the tibial tray should be avoided, and most likely the condition of minimum damage to the patient is to leave the existing tibial tray and the insert clipped with no additional fixation screw.However, the behaviour of the prosthesis in these conditions cannot be predicted.
Event or Problem Description
The patient came in reporting pain after falling.About 1 year and 9 months after the primary surgery, the surgeon observed that the screw in the patient's poly had broken and that the poly had partially dislocated.The surgeon removed the broken screw and revised the poly.The surgery was completed successfully.3.5nm torque limiter used.

• Brand Name: GMK-REVISION TIBIAL INSERT PS FIXED SIZE 2/12MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14189887
• Report Number: 3005180920-2022-00279
• Device Sequence Number: 4481410
• Product Code: JWH
• UDI-Device Identifier: 07630030816581
• UDI-Public: 07630030816581
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 04/22/2022

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: 02/23/2022
• Device Model Number: 02.07.0212PSF
• Device Catalogue Number: 02.07.0212PSF
• Device Lot Number: 168560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2017
• 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: Disability; Required Intervention
• Patient Sex: Female