BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC COMPLETE PRIMARY FEMORAL POROUS COATED STEM REDUCED DISTAL 18X156MM

    MDR report key: 6015536 · Received October 10, 2016

    Report

    Report Number
    0001825034-2016-04044
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    November 18, 2015
    Report Date
    October 6, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. TAPERLOC COMPLETE PRIMARY FEMORAL POROUS COATED STEM REDUCED DISTAL 18X156MM HIGH OFFSET TYPE 1 TAPER. EXAMINATION OF DEVICE RECORDS FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION, AS A TEAR AND SCRATCHING OF THE POUCH WERE IDENTIFIED IN A PHOTO. IT WAS NOTED DURING THE EVALUATION, THAT THE ADHESION AROUND THE BLISTER WAS WELL COVERED, INDICATING THAT STERILE BARRIER WAS INTACT. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, AS ALL THE PACKAGING MATERIAL WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PROCEDURE, THE INNER PACKAGING OF THE FEMORAL STEM WAS FOUND TO BE DAMAGED. ANOTHER STEM OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665814 TAPERLOC COMPLETE PRIMARY FEMORAL POROUS COATED STEM REDUCED DISTAL 18X156MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 3113906

    Patients

    Seq Age Sex Outcome Treatment
    1