BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX90-2 ARCOM HW/32MM LINER SZ 44

    MDR report key: 3863797 · Received June 10, 2014

    Report

    Report Number
    0001825034-2014-05409
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK042989
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05408 / 05409).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 DUE TO CHRONIC DISLOCATION. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340965 RX90-2 ARCOM HW/32MM LINER SZ 44 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 962830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R