BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6151292 · Received December 7, 2016

    Report

    Report Number
    3005180920-2016-00644
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 15, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES: THE SURGEON PLANNED TO OPERATE AND HOPEFULLY JUST REPLACE THE INSERT (THE SCREW IS CURRENTLY SITTING IN THE BACK OF HIS KNEE AGAINST THE FEMORAL COMPONENT); BATCH REVIEW PERFORMED ON (B)(6) 2016. LOT 120371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 APRIL 2012. EXPIRATION DATE: 2017-03-31. 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: AT 3.5 YEARS AFTER PRIMARY TKA, THE INSERT LOCKING SCREW LOOSENED AND MOVED FROM ORIGINAL SEATING. THIS CAUSED DECISION TO REMOVE THE SCREW AND CHANGE THE INSERT. THE CAUSE FOR THE EVENT CANNOT BE DETERMINED WITH CERTAINTY; IT IS POSSIBLE THAT THE TIGHTENING TORQUE WAS INSUFFICIENT BUT THERE IS NO EVIDENCE TO THIS. IF THE FEMORAL COMPONENT HAS NOT BEEN DAMAGED BY CONTACT WITH THE LOOSE SCREW, NO FURTHER CLINICAL CONSEQUENCES SHOULD BE EXPECTED. THIS CAN BE VERIFIED AT REVISION SURGERY BY VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 16 JANUARY 2017 AND INCLUDES: THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. ON 17 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR UPDATED THE CLINICAL EVALUATION BASED ON THE NEW INFORMATION AND COMMENTED AS FOLLOWS: REPORT OF REVISION SURGERY WAS LATER MADE AVAILABLE. APPARENTLY THE SCREW COULD NOT BE RETRIEVED DUE TO ITS LOCATION, WHICH WAS CONSIDERED SAFE BY THE SURGEONS. THE SCREW WAS DESIGNED AND MANUFACTURED FOR LONG-TERM IMPLANTATION, SO THERE IS NO CONSEQUENCE TO BE EXPECTED, UNLESS IT MOVES FROM THE CURRENT POSITION AND GETS TRAPPED IN ARTICULATION AGAIN. THERE IS NO REPORT DESCRIBING THE CONDITION OF THE FEMORAL COMPONENT, BUT IT SHOULD BE ASSUMED THAT IT WAS UNDAMAGED BECAUSE NO REVISION WAS PERFORMED. THEREFORE, NO FURTHER CONSEQUENCES SHOULD BE EXPECTED UNLESS THE SCREW MOVES AGAIN. ON 06 FEBRUARY 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE EXPLANTED TIBIA INSERT AND COMMENTED AS FOLLOWS: THE INSERT IS FOUND DAMAGED ON THE POSTERIOR PART OF THE MEDIAL ARTICULAR SURFACE, WITH 2 EVIDENT DENTS AND SCRATCHES. THEY WERE MOST LIKELY CAUSED BY THE SCREW THAT, ONCE OUT FROM ITS SEAT, WAS INTERPOSED BETWEEN THE ARTICULAR SURFACE OF THE FEMORAL COMPONENT AND THE TIBIAL INSERT. THE MOST-LIKELY CAUSE FOR THE PROGRESSIVE SELF-UNSCREWING OF THE SCREW AFTER 3,5 YEARS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE DURING PRIMARY SURGERY. USING A SCREWDRIVER PROVIDED WITH A TORQUE LIMITATION WOULD PREVENT THIS EVENT. THIS TYPE OF SCREWDRIVER IS ALREADY AVAILABLE ON DEMAND. DURING THE REVISION SURGERY, THE SCREW WAS NOT REMOVED FROM ITS LOCATION, JUDGED SAFE FROM THE SURGEON. NO CONSEQUENCES ARE EXPECTED UNLESS IT MOVES FROM THE CURRENT POSITION AND COMES BACK INTO THE JOINT. DURING THE REVISION SURGERY ONLY THE PE INSERT WAS REMOVED. WE CAN SUPPOSED THAT THE FEMORAL AND THE TIBIA COMPONENTS WERE FOUND UNDAMAGED.

    Description of Event or Problem · 1

    THE PATIENT RETURNED COMPLAINING OF A GRINDING FEELING IN THE KNEE JOINT. ON EXAMINATION THE SURGEON COULD SEE A SCREW AT THE BACK OF THE KNEE WHICH HE BELIEVED TO BE THE SCREW USED TO SECURE THE POLY INSERT INTO THE TIBIAL BASEPLATE. THE SURGEON PLANNED TO OPERATE AND REPLACE THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801778 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 120371

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention