BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM RIGHT

    MDR report key: 6157867 · Received December 9, 2016

    Report

    Report Number
    3005180920-2016-00646
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 9, 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 05 DECEMBER 2016. LOT 157602: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 APRIL 2016. EXPIRATION DATE: 2021-03-30. 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. GMK TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT, CODE 02.07.1202R, LOT. 163307 (K090988). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 JULY 2016. EXPIRATION DATE: 2021-07-17. 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 07 DECEMBER 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 AND SCRATCHES. THE POSTERIOR "CLIPPING" TOOTH 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. AN INSERT OF THE SAME BATCH WAS SUCCESSFULLY IMPLANTED LATER.

    Description of Event or Problem · 1

    TIBIAL INSERT DID NOT FIT INTO THE TIBIAL TRAY, DESPITE THERE WERE NO OBSTACLES. THE SURGEON REPLACED THE TIBIAL INSERT WITH A NEW ONE (SAME CODE, DIFFERENT LOT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815001 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 157602

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other