BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L

    MDR report key: 18274789 · Received December 6, 2023

    Report

    Report Number
    3005180920-2023-00967
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 6, 2023
    Report Date
    December 6, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862618
    PMA / PMN Number
    K140826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 NOVEMBER 2023. LOT 143217: 50 ITEMS MANUFACTURED AND RELEASED ON 26-SEPT-2014. EXPIRATION DATE: 2019-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT IN 2016, PRIMARY TKA IS PERFORMED ON A RELATIVELY YOUNG PATIENT. A SCREW IS USED TO SECURE THE INSERT TO THE TIBIAL BASEPLATE. 3 YEARS LATER, THE SCREW IS STILL IN PLACE, BUT LOOKING WITH ATTENTION AT THE XRAY IT APPEARS THAT IT MAY HAVE STARTED A PROCESS OF SELF-UNSCREWING. IN 2021, AT 5 YEARS, THE SCREW HAS BACKED OUT COMPLETELY AND IS NOW LOOSE IN THE VICINITIES OF THE JOINT, BUT DEFINITELY FAR AWAY FROM THE ARTICULAR SURFACES. NOW, AFTER 7 YEARS, IT'S STILL THERE. THE SURGEONS DECIDED THAT THE POSITION OF THE SCREW IS NOT DANGEROUS FOR THE PATIENT AND LEFT IT THERE. THE PATIENT IS ADVISED AND MONITORED, BUT THERE IS NO CLINICAL ANOMALY AND NONE SHOULD BE EXPECTED. THE MOST LIKELY CAUSE OF THIS EVENT IS INSUFFICIENT TIGHTENING TORQUE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 0

    AT ABOUT 5 YEARS FROM THE PRIMARY, DURING A FOLLOW-UP VISIT, IT WAS NOTED FROM THE X-RAYS THAT THE INLAY LOCKING SCREW WAS LOOSE IN THE POSTEROLATERAL ASPECT OF THE KNEE. ABOUT 7 YEARS AFTER THE PRIMARY SURGERY, A SECOND FOLLOW-UP SHOWED THAT THE SCREW HAS NOT MOVED. AT THIS TIME, AN ADDITIONAL/REVISION SURGERY IS NOT PLANNED, THE PATIENT DOES NOT FEEL ANY PAIN AND HAS A FULL RANGE OF MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771567 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 143217 07630030862618

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other