BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

    MDR report key: 8050711 · Received November 8, 2018

    Report

    Report Number
    3005180920-2018-00878
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 12, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817519
    PMA / PMN Number
    K103170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE UHMWPE SEMI-CONSTRAINED REVISION INSERT: SOME DENTS AND SCRATCHES CAN BE NOTED ON THE DISTAL SURFACE OF THE INSERT. THE POSTERIOR FEATURES OF THE 'SNAPPING' MECHANISM HAVE BEEN PLASTICALLY DEFORMED AND DAMAGED, ESPECIALLY IN ONE SIDE. THEY BOTH PRESENT A SORT OF INCISION WITH THE NEGATIVE SHAPE OF THE CLIPPING "TOOTH" OF THE BASEPLATE. WE CAN SUPPOSE THAT, IN THE FIRST ATTEMPT TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS POSTERIORLY NOT WELL POSITIONED (WE CAN SUPPOSE THAT THE INSERTION WAS DIFFICULT BECAUSE THE JOINT WAS TIGHT USING A 20MM THICK INSERT; THAT'S THE REASON WHY WAS THEN USED A 17MM INSERT). IN THIS ATTEMPT THE INSERT WAS PUSHED POSTERIORILY AND WAS PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ATTEMPTS. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08 NOVEMBER 2018: LOT 140476: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2014. EXPIRATION DATE: 2019-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE TIBIAL INSERT (22MM) WOULD NOT SNAP INTO THE TIBIAL TRAY. THE SURGEON ENDED UP DROPPING TO A 17MM INSERT AND THAT WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893140 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 140476 07630030817519

    Patients

    Seq Age Sex Outcome Treatment
    0 Other