BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MALLORY-HEAD STEM

    MDR report key: 3250413 · Received July 26, 2013

    Report

    Report Number
    0001825034-2013-02939
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED AS LIMITED INFORMATION WAS AVAILABLE: PRODUCT IDENTIFICATION & EXPIRY DATE. DATE IMPLANTED - 2002, EXACT DATE IS UNKNOWN . MANUFACTURE DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE IN 2002. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, DUE TO LOOSENING OF THE FEMORAL STEM AND PAIN. IT WAS NOTED INTRAOPERATIVELY THAT IMPROPER CEMENTING TECHNIQUE HAD BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349782 UNKNOWN MALLORY-HEAD STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R