BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM LEFT

    MDR report key: 6529597 · Received April 28, 2017

    Report

    Report Number
    3005180920-2017-00218
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 29, 2017
    Report Date
    June 28, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2017 AND INCLUDES: THE SURGEON SWAPPED THE POLY AS PLANNED ON (B)(6) 2017. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(4) 2017, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: RADIOLOGIC IMAGE PROVIDED SHOWS THE PRESENCE OF A LOOSENED INSERT FIXATION SCREW OCCURRED 1 YEAR AND 7 MONTHS AFTER PRIMARY SURGERY. THIS EVENT MAY BE CAUSED BY INSUFFICIENT TIGHTENING TORQUE BUT THE REAL CAUSE CAN'T BE DETERMINED. IMMEDIATE REMOVAL IS STRONGLY RECOMMENDED. BATCH REVIEW PERFORMED ON 24 APRIL 2017. LOT 143214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 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.

    Additional Manufacturer Narrative · 1

    ON 13 JUNE 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION THE EXPLANTED COMPONENTS, AND COMMENTED AS FOLLOWS: RADIOGRAPHIC IMAGES SHOW THE PRESENCE OF A LOOSENED INSERT SAFETY SCREW OCCURRED 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY. THE SCREW WAS FOUND IN THE POSTERIOR PART OF THE JOINT. THE MOST-LIKELY CAUSE FOR SELF-UNSCREWING OF THE SCREW AFTER FEW MONTHS FROM IMPLANTATION, WAS INSUFFICIENT TIGHTENING TORQUE. SOME DENTS AND SCRATCHES HAVE BEEN NOTED ON THE ARTICULAR SURFACE OF THE TIBIAL INSERT, IN PARTICULAR ON THE TIBIA SPINE AND THE LATERAL ARTICULAR SURFACE. 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. AS CONSEQUENCE, THE SCREW LOOKS DAMAGED IN ITS THREADED PART, WITH PLASTIC DEFORMATION OF THE THREAD.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE SURGEON TOOK X-RAYS AND DETERMINED THE SCREW HAD BACKED OUT OF THE POLY. NO TRAUMA WAS REPORTED. THE CAUSE OF THE SCREW BACKING OUT IS UNKNOWN. THE SURGEON PLANS TO REMOVE THE SCREW AND SWAP THE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311854 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/11 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 143214

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention