BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00582

    MDR report key: 7731854 · Received July 30, 2018

    Report

    Report Number
    3005180920-2018-00582
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    July 9, 2018
    Report Date
    September 7, 2018
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE EXPLANTED COMPONENTS PERFORMED ON 28 AUGUST 2018 BY R&D PRODUCT MANAGER: HINGE INLAY SECURE SCREW: THE SCREW WAS FOUND LOOSENED AND STUCK AT THE TOP OF THE INLAY AFTER ONE YEAR AND 8 MONTHS FROM PRIMARY SURGERY. THE LAST THREAD OF THE SCREW IS DAMAGED AND PLASTICALLY DEFORMED. HEAD OF THE SCREW PRESENT SOME SCRATCHES AND INCISIONS. IT IS POSSIBLE THAT, ONCE BACKED OUT FROM THE INSERT, THE HEAD OF THE SCREW WAS IN CONTACT WITH THE FEMORAL COMPONENT AND WAS PRESSED UNDER THE BODY LOAD. FEMORAL COMPONENT: ARTICULAR SURFACE OF THE FEMORAL COMPONENT PRESENTS SOME SCRATCHES ON THE DISTAL ARTICULAR SURFACE ON BOTH THE MEDIAL AND THE LATERAL SIDE. WE CAN SUPPOSE THAT THESE DAMAGES HAVE BEEN CAUSED BY THE SCREW THAT, ONCE UNSCREWED, WENT IN CONTACT WITH THE ARTICULAR SURFACE OF THE FEMORAL COMPONENT A LOT OF CEMENT AND SOME RESIDUAL BONE ARE PRESENT ON THE INTERNAL SURFACE OF THE EXPLANTED COMPONENT. TIBIAL COMPONENT: A BIG DENT / INCISION CAN BE NOTED ON THE PROXIMAL SURFACE OF THE TIBIA TRAY. THIS HAS BEEN MOST LIKELY CAUSED DURING THE ATTEMPT TO REMOVE THE COMPONENTS. SOME RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF THE TIBIA TRAY AND THE AUGMENTS. IT IS NOT POSSIBLE TO FIND AN EXPLANATION FOR THIS EVENT. IN ORDER TO ACHIEVE THE CORRECT TIGHTENING TORQUE OF THE INLAY SECURE SCREW, A TORQUE LIMITING SCREWDRIVER (3 NM) IS SUPPLIED AND ITS USE IS MANDATORY. THE ONLY CAUSE THAT WE CAN SUPPOSE FOR THIS EVENT IS INSUFFICIENT TIGHTENING TORQUE, EITHER DUE TO A MALFUNCTION OF THE TORQUE LIMITING DEVICE OR TO IMPROPER USE (I.E. LIMITING TORQUE WAS NOT REACHED DURING TIGHTENING). BUT THIS REMAIN ONLY A SUPPOSITION WITHOUT THE POSSIBILITY TO BE VERIFIED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 150743: 15 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INLAY LOCKING SCREW UNSCREWING, THE FEMORAL COMPONENT WAS SCRATCHED AND REPLACED.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention