BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5694977 · Received June 2, 2016

    Report

    Report Number
    3005180920-2016-00262
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 5, 2016
    Report Date
    August 25, 2016
    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

    ON 29 JULY 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED UHMWPE INSERT AND COMMENTED AS FOLLOWS: THE 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 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. ON 03 AUGUST 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON 12 AUGUST 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 02 JUNE 2016. LOT 154366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 DECEMBER 2015. EXPIRATION DATE: 2020-12-05. 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 T3-I4 LEFT, CODE 02.12.T3I4L, LOT. 153736 (K121416) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 OCTOBER 2015. EXPIRATION DATE: 2020-10-05. 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.

    Description of Event or Problem · 1

    DURING SURGERY WHEN THE SURGEON WAS INSERTING THE POLY, THE POLY WOULD NOT SEAT. THE SURGERY WAS DELAYED APPROXIMATELY 15 MINUTES. THE SURGEON OPENED A NEW POLY TO COMPLETE THE SURGERY SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE. THE INSERT IS BEING SENT BACK TO MEDACTA INTERNATIONAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348954 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 154366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other