BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H RADIAL 3-HOLE SHELL 56MM

    MDR report key: 3970881 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06646
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    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 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY.¿ NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06645 / 06646).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6), 2007. SUBSEQUENTLY, PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN, LOOSENING, LACK OF MOBILITY, BONE/TISSUE DAMAGE AND METALLOSIS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447124 M/H RADIAL 3-HOLE SHELL 56MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 020050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention