BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RLC LNR HW SZ26

    MDR report key: 3901974 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05701
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00131, 05701 & 05702).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO POLY WEAR AND (B)(6) 2014 DUE TO INSTABILITY AND DISLOCATION. THE MODULAR HEAD AND POLYETHYLENE LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380963 ARCOMXL 36MM RLC LNR HW SZ26 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 831570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R