BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 6860922 · Received September 13, 2017

    Report

    Report Number
    3005180920-2017-00516
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 13, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    PMA / PMN Number
    K103170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE (B)(6) MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED UHMWPE INSERT AND COMMENTED AS FOLLOWS: THE POSTERIOR "CLIPPING" FEATURES OF THE INSERT HAVE BEEN PLASTICALLY DEFORMED AND DAMAGED IN THE LATERAL SIDE. IT PRESENTS A SORT OF INCISION WITH THE NEGATIVE SHAPE OF THE CLIPPING "TOOTH" OF THE BASEPLATE. WE CAN SUPPOSE THAT PROBABLY, IN THE FIRST ATTEMPT TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT POSTERIORLY WELL POSITIONED. IN THIS ATTEMPT THE INSERT WAS PUSHED POSTERIORLY AND WAS PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ATTEMPTS. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED. SOME SCRATCHES CAN BE IDENTIFIED ON THE ANTERIOR SURFACE OF THE INSERT AS WELL, MOST LIKELY CAUSED DURING THE ATTEMPT TO EXPLANT THE COMPONENT. BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 131096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 MARCH 2013. EXPIRATION DATE: 2018-01-31. 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. GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 RIGHT, CODE 02.07.0682R, LOT. 164179 (K123721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 OCTOBER 2016. EXPIRATION DATE: 2021-09-20. 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

    WHEN IMPLANTING THE INSERT, THE INSERT WOULD NOT SEAT PROPERLY. THE SURGEON REQUESTED A SECONDARY INSERT TO COMPLETE THE SURGERY. THERE WAS APPROXIMATELY A 5 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. IMPLANT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643479 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 131096 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other