BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM RIGHT

    MDR report key: 6215343 · Received December 30, 2016

    Report

    Report Number
    3005180920-2016-00687
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    November 30, 2016
    Report Date
    March 1, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 27 DECEMBER 2016. LOT 162638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2016. EXPIRATION DATE: 2021-07-14. 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-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 RIGHT, CODE 02.07.1205R, LOT. 162465 (K090988), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2016. EXPIRATION DATE: 2021-06-01. 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 28 FEBRUARY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED UHMWPE INSERT AND COMMENTED AS FOLLOWS: THE MEDIAL AND LATERAL SIDE OF THE POSTERIOR BOTTOM SURFACE OF THE INSERT PRESENTS SOME DENTS AND SCRATCHES. 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. 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.

    Description of Event or Problem · 1

    WHEN THE SURGEON WAS IMPLANTING THE INSERT, THE INSERT WOULD NOT SNAP INTO THE TIBIAL TRAY. THE SURGEON ATTEMPTED TO IMPLANT THE INSERT FOR APPROXIMATELY 15 MINUTES. THE SURGEON USED A SECONDARY INSERT TO COMPLETE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE. THE INSERT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865386 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 162638

    Patients

    Seq Age Sex Outcome Treatment
    1 Other