BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA BIOLOX FORTE CERAMIC

    MDR report key: 3132741 · Received May 29, 2013

    Report

    Report Number
    1020279-2013-00285
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT WAS RETURNED AND EVALUATED TO DETERMINE THE CAUSE OF THE REPORTED INCIDENT. THE AS RECEIVED FRACTURED CERAMIC HEAD WAS EXAMINED VISUALLY AND STEREOMICROSCOPICALLY. THE FEMORAL HEAD FRACTURED INTO THREE BIG FRAGMENTS AND 14 SMALL FRAGMENTS. THE LOT NUMBER IS UNABLE TO BE DETERMINED. VISUAL ANALYSES OF THE TAPER BORE SURFACES OF THE LARGER HEAD FRAGMENTS SHOWED METAL TRANSFER AND INDICATED THE MOST LIKELY FRACTURE INITIATION SITE WAS NEAR THE GAGE POINT. THE FRACTURE OF THE ALUMINA FEMORAL HEAD LIKELY ORIGINATED NEAR THE GAGE POINT REGION. THIS REGION IS KNOWN TO BE THE HIGHEST STRESS AREA BASED ON FINITE ELEMENT ANALYSIS..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236135 DELTA BIOLOX FORTE CERAMIC HIP IMPLANT JDH SMITH & NEPHEW, INC. 71330320

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R