BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM RIGHT

    MDR report key: 5798377 · Received July 15, 2016

    Report

    Report Number
    3005180920-2016-00357
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    June 16, 2016
    Report Date
    September 21, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 16 JUNE 2016 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. ON 14 JULY 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: DOCUMENTATION SHOWS PROGRESSIVE SELF-UNSCREWING OF INSERT FIXATION SCREW IN TKA. THE MOST LIKELY CAUSE FOR THIS EVENT IS INSUFFICIENT TIGHTENING AT OPERATION, BUT IT CANNOT BE PROVEN. THERE IS NO EVIDENCE THAT A CLINICAL CONDITION MAY HAVE GENERATED THIS PROBLEM. BATCH REVIEW PERFORMED ON 14 JULY 2016. LOT 140351: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2014. EXPIRATION DATE: 2019-01-31. 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. NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    ON 13 SEPTEMBER 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED EXPLANTS AND COMMENTED AS FOLLOWS: EXPLANTED TIBIA INSERT: MANY SCRATCHES AND SOME SMALL CRATERS CAN BE SEEN ON THE ARTICULAR SURFACE OF THE LATERAL CONDYLE OF THE TIBIA INSERT. THOSE SCRATCHES WERE MOST LIKELY CAUSED BY THE PRESENCE OF THE SCREW THAT, DISLOCATED FROM THE TIBIA COMPONENT, FOUND INTERPOSED BETWEEN THE ARTICULAR SURFACE OF THE TIBIA INSERT AND THE FEMORAL COMPONENT. EXPLANTED SCREW: FROM VISUAL INSPECTION OF THE EXPLANTED SCREW IT COULD BE SEEN THAT THE THREADED PART SCREW WAS DAMAGED. THE THREAD LOOKS PRESSED AND PLASTICALLY DEFORMED. THE DEFORMATION WAS MOST LIKELY DUE TO THE BODY-WEIGHT LOAD ON THE SCREW WHEN, UNSCREWED AND DISLOCATED FROM THE TIBIAL INSERT, IT WAS FOUND INTERPOSED BETWEEN THE INSERT AND THE FEMORAL COMPONENT. NO POSSIBLE ROOT CAUSES FOR THE EVENT CAN BE DETECTED FROM VISUAL INSPECTION. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. USING A SCREWDRIVER PROVIDED WITH A TORQUE LIMITATION WOULD PREVENT THIS EVENT. THIS TYPE OF SCREWDRIVER IS ALREADY AVAILABLE ON DEMAND.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON NOTICED THE SCREW HAD BACKED OUT THE INSERT. THE SURGEON PLANS TO SWAP THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452922 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM RIGHT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 140351

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention