BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HEAD 36MM

    MDR report key: 3813578 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04068
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 14 STATES, "INTRAOPERATIVE AND POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT ALLEGATIONS OF PAIN. 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
    290279 CER BIOLOXD OPTION HEAD 36MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 404200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R