BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 15931582 · Received December 7, 2022

    Report

    Report Number
    3005180920-2022-00920
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 7, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 NOVEMBER 2022 LOT 143392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2014. EXPIRATION DATE: 2019-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SINCE RELEASE TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: PROGRESSIVE UNSCREWING OF THE INSERT FIXATION SCREW IN A TKA IMPLANTED CORRECTLY 8 YEARS BEFORE. THE TORQUE-LIMITING DEVICE HAD NOT BEEN USED AT THE TIME. THE SCREW IS PRESENTLY IN A POSITION WHERE NO DAMAGE IS TO BE EXPECTED, UNLESS THE PATIENT FEELS IT - BUT THIS SEEMS NOT TO BE THE CASE. OF COURSE THE SCREW COULD MIGRATE FURTHER AND BE LOCATED IN A POSITION WHERE REMOVAL BECOMES NECESSARY. THE REASONS FOR SELF-UNSCREWING OF THE FIXATION SCREW CANNOT BE DETERMINED WITH CERTAINTY: ONE POSSIBILITY, THAT COULD BE REPRODUCED IN THE LABORATORY, IS INSUFFICIENT TIGHTENING FORCE, BUT OTHER UNKNOWN FACTORS MAY ALSO HAVE PLAYED A ROLE.

    Description of Event or Problem · 0

    ABOUT 8 YEARS AFTER THE PRIMARY SURGERY, THE INSERT SCREW UNSCREWED. AT THIS TIME, AN ADDITIONAL/REVISION SURGERY IS NOT PLANNED, THE PATIENT DOES NOT FEEL ANY PAIN OR DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470263 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT (FIXATION SCREW) JWH MEDACTA INTERNATIONAL SA 02.12.0410FR 143392 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other