BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HWAL ARCOMXL ALLPOLY 32IDX48OD

    MDR report key: 4192512 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08216
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK042051
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY MAY ALSO CONTRIBUTE TO THESE CONDITIONS. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE APPROXIMATELY 25 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO OSTEOLYSIS. SUBSEQUENTLY, PATIENT UNDERWENT A SECOND REVISION PROCEDURE ON (B)(6) 2014 DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671651 HWAL ARCOMXL ALLPOLY 32IDX48OD PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 911150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R