BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 2411126 · Received January 11, 2012

    Report

    Report Number
    0001825034-2012-00031
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    November 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL VISUAL EXAMINATION OF RETURNED DEVICE WAS UNREMARKABLE FOR SOURCE OF INFECTION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS MEDWATCH REPORT IS 4 OF 4 REPORTS ASSOCIATED WITH THIS COMPLAINT (1825034-2012-00028-1, 1825034-2012-00029-1, 1825034-2012-00030-1, 1825034-2012-00031-1).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO DETERMINE THE CAUSE OF REPORTED ISSUE. PACKAGE INSERTS LIST THE FOLLOWING AS A POSSIBLE ADVERSE EFFECT: EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. UPON COMPLETION OF EVALUATION, A FOLLOW-UP MDR WILL BE REPORTED. THIS MEDWATCH REPORT IS 4 OF 4 REPORTS ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL HIP PROCEDURE ON (B)(6), 2011. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE IN (B)(6) 2011 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CER BIOLOXD OPTION HD 40MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET ORTHOPEDICS N/A 886910

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R