BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 1/10 MM RIGHT

    MDR report key: 6112779 · Received November 18, 2016

    Report

    Report Number
    3005180920-2016-00596
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 14 NOVEMBER 2016. LOT 144622: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2014. EXPIRATION DATE: 2019-08-31. 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 TIBIAL TRAY FIXED CEMENTED SIZE 1 RIGHT, CODE 02.07.1201R, LOT. 147017 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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. ON 18 NOVEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED INSERT AND COMMENTED AS FOLLOWS: THE LATERAL SIDE OF THE POSTERIOR BOTTOM SURFACE OF THE INSERT PRESENTS SOME DENTS. 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 POSTERIORILY AND WAS PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ATTEMPTS. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED. AN INSERT OF THE SAME BATCH WAS SUCCESFULLY IMPLANTED LATER.

    Description of Event or Problem · 1

    TIBIAL INSERT DID NOT FIT INTO THE TIBIAL TRAY. AFTER MANY TIMES STRUGGLE, THE SURGEON REPLACED WITH A NEW INSERT (SAME LOT NUMBER). THE NEW ONE FIT EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764372 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 1/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 144622

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other