BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCM ASCENT PRIMARY LIPPER BEARING 14MM THICK X 63/67 MM WIDE

    MDR report key: 2810214 · Received October 31, 2012

    Report

    Report Number
    0001825034-2012-02304
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK982869
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF NONCONFORMING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. DURING PROCEDURE, SURGEON NOTICED MARKINGS ON IMPLANT. AS A RESULT, ANOTHER IMPLANT WAS OPENED TO FINISH THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCM ASCENT PRIMARY LIPPER BEARING 14MM THICK X 63/67 MM WIDE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 888240

    Patients

    Seq Age Sex Outcome Treatment
    1