BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    MDR report key: 9383331 · Received November 27, 2019

    Report

    Report Number
    3005180920-2019-00986
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817069
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 NOVEMBER 2019: LOT 121448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2012. EXPIRATION DATE: 2017-06-30. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 6 YEARS AFTER PRIMARY CEMENTED TKA THE INSERT FIXATION SCREW IS FOUND LOOSE POSTERIOR TO THE ARTICULATING SURFACES. IT IS VERY POSSIBLE THAT THE SCREW HAS BACKED OUT LONG BEFORE IT WAS DETECTED BECAUSE IT IS IN A POSITION WHERE IT IS PROBABLY COMPLETELY ASYMPTOMATIC. THE REASON FOR THE SELF-UNSCREWING COULD BE INSUFFICIENT TIGHTENING TORQUE AT SURGERY, BUT OTHER CAUSES MAY PLAY A ROLE. WE DO NOT SEE OTHER REASONS THAT COULD SUGGEST A TOTAL REVISION OF THE IMPLANTS. THE DECISION ON THE OPPORTUNITY FOR A SURGERY AIMED AT REMOVING THE SCREW IS UP TO THE SURGEON EXCLUSIVELY. FROM THE TECHNICAL POINT OF VIEW, IT IS VERY LIKELY THAT A 10MM THICK INSERT MAY WORK WELL INDEFINITELY IN ABSENCE OF SUCH SCREW, PARTICULARLY BECAUSE IT HAS ALREADY DONE SO.

    Description of Event or Problem · 1

    DURING AN AMBULANCE VISIT IN THE HOSPITAL LKH-STOLZALPE ON (B)(6) 2019, THE PHYSICIAN DR. (B)(6) DETECTED THE LOOSE INLAY FIXATION SCREW IN THE BACK OF THE JOINT ON THE X-RAY PICTURES. REVISION SURGERY HAS BEEN THEN PERFORMED, MORE THAN 6 YEARS AFTER PRIMARY SURGERY. ALL COMPONENTS HAVE BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182290 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM KNEE TIBIAL LINER JWH MEDACTA INTERNATIONAL SA 121448 07630030817069

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention