BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL RLC 32MM 10 DEG SZ23

    MDR report key: 3162403 · Received June 11, 2013

    Report

    Report Number
    0001825034-2013-01897
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 1 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-01897 / 01898).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED (B)(6) 2013 DUE TO DISLOCATION. THE LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262039 ARCOMXL RLC 32MM 10 DEG SZ23 PROSTHSIS, HIP LZO BIOMET ORTHOPEDICS N/A 440060

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R