BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT

    MDR report key: 6072822 · Received November 2, 2016

    Report

    Report Number
    3005180920-2016-00557
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    October 3, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2016. LOT 151116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 JULY 2015. EXPIRATION DATE: 2020-05-31. 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. DEVICE NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 01 DECEMBER 2016 THE (B)(4) 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 MEDIAL SIDE. IT PRESENTS A SORT OF INCISION WITH THE NEGATIVE SHAPE OF THE "CLIPPING" TOOTH OF THE BASEPLATE. THE POSTERIOR BOTTOM SURFACE OF THE INSERT IS PLASTICALLY DEFORMED IN CORRESPONDENCE OF THE MEDIAL 'CLIPPING' TOOTH. HEREIN THE SHAPE OF THE POSTERIOR LIP OF THE BASEPLATE IS TRACED. 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.

    Description of Event or Problem · 1

    AT FINAL IMPLANTATION STEP, THE INSERT WOULD NOT ENGAGE IN TRAY. EVERYTHING HAD BEEN CLEANED AND CHECKED AGAIN, BUT THE INSERT DID NOT STILL SEAT. THEREFORE ANOTHER INSERT WAS USED AND IMPLANTED SUCESSFULLY INTO THE EXISTING TIBIAL TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725612 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 151116

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other