BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L

    MDR report key: 7309745 · Received March 2, 2018

    Report

    Report Number
    3005180920-2018-00116
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862533
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS ON 16 FEBRUARY 2018: ONE YEAR AFTER PRIMARY TKR THE INSERT FIXATION SCREW GOT LOOSE IN THE JOINT. IT WAS IMMEDIATELY REMOVED AND THE POLY WAS EXCHANGED. THE CAUSE FOR SELF-UNSCREWING OF THE INSERT SCREW IS NOT KNOWN: ONE POSSIBILITY IS INSUFFICIENT TIGHTENING TORQUE, BUT OTHER UNKNOWN CONDITIONS MAY ALSO PLAY A ROLE BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 143213: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 NOVEMBER 2014. EXPIRATION DATE: 2019-08-31 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. PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE EXPLANTED TIBIAL INSERT AND RELATIVE SECURE FIXATION SCREW PERFORMED BY R&D PRODUCT MANAGER ON 02 MARCH 2018 : TIBIAL INSERT FIXATION SCREW BAKED OUT FROM THE INSERT AND WAS FOUND LOOSENED IN THE JOINT AFTER 1 YEAR FROM PRIMARY IMPLANTATION. SOME DENTS AND SCRATCHES CAN BE IDENTIFIED ON THE ARTICULAR SURFACE OF THE INSERT WITH TRACE OF THE THREADED PART OF THE SCREW. THE SCREW LOOKS DAMAGED IN ITS THREADED SHAFT THAT IS PLASTICALLY DEFORMED. THESE DAMAGES WERE MOST LIKELY CAUSED BY THE SCREW THAT, ONCE BAKED OUT FROM THE INSERT, WAS LOOSENED BETWEEN THE INSERT AND THE FEMORAL COMPONENT AND UNDERWENT BODY LOAD. IT IS NOT POSSIBLE TO IDENTIFY ANY POSSIBLE ROOT CAUSE FOR THE EVENT ANALYSING THE PICTURES SENT. WE CAN ONLY SUPPOSE THAT INSUFFICIENT TIGHTNING TORQUE APPLIED TO THE SCREW DURING FIXATION COULD HAVE LEAD TO THIS UNLIKELY EVENT. THE USE OF A TORQUE LIMITER SCREWDRIVER TO TIGHT THE SCREW AT 3,5NM IS CURRENTLY MANDATORY FOR SECURE SCREW FIXATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018 SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE SCREW BACKED OUT OF THE POLY. REVISION SURGERY PERFORMED ON (B)(6) 2018 DUE TO SCREW BACKED OUT OF THE INSERT. THE SCREW WAS NOT IMPLANTED USING A TORQUE LIMITING DRIVER. THE SURGEON IMPLANTED A NEW SCREW WITH THE INSERT. HE DID USE A TORQUE DRIVER THIS TIME AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153177 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 143213 07630030862533

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention