BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE FLEX TIBIAL INSERT SIZE 4 / 10MM LEFT

    MDR report key: 5172935 · Received October 24, 2015

    Report

    Report Number
    3005180920-2015-00245
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 23, 2015
    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 REVIEW PERFORMED ON 16 OCTOBER 2015: LOT 147252: 75 ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. GMK TIBIAL TRAY FIXED CEMENTED CODE 02.07.1204L # 4 R LOT. 150912 (K090988): BATCH REVIEW PERFORMED ON 20 OCTOBER 2015: LOT 150912: 35 ITEMS MANUFACTURED AND RELEASED ON 12 MAY 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. INSPECTION OF THE RETRIEVED ITEM DONE ON THE 15TH OF OCTOBER 2015 BY (B)(4) PROJECT MANAGER: DURING THE VISUAL INSPECTION OF THE INSERT WAS NOTED THAT THE POSTERIOR "CLIPPING" FEATURES OF THE INSERT HAVE BEEN PLASTICALLY DEFORMED AND DAMAGED BOTH IN THE MEDIAL AND THE LATERAL SIDE. ONE OF THIS FEATURE PRESENT 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 PERMANENTLY DAMAGED WITHOUT POSSIBILITY TO BE CLIPPED IN THE FOLLOWING ONES. WE CAN STATE THAT THE EVENT IS NOT IMPLANT RELATED. ON 21 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ABOVE DESCRIBED. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY THE SURGEON COULD NOT GET THE TIBIAL INSERT TO SEAT ON THE TIBIAL BASEPLATE. AFTER 15 MINUTES OF ADJUSTING THE SURGEON REQUESTED A NEW TIBIAL INSERT. THE NEW LINER SAT IMMEDIATELY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. EXPLANT WILL BE RETURNED NO X-RAYS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705854 GMK SPHERE FLEX TIBIAL INSERT SIZE 4 / 10MM LEFT FIXED PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 147252

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR