BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 32 X -3.5

    MDR report key: 3221533 · Received July 9, 2013

    Report

    Report Number
    9613350-2013-01712
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. OTHER SOURCE DOCUMENTS (SURGICAL REPORT) WERE PROVIDED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA HEAD, 12/14, 32X -3.5 ON THE RIGHT SIDE ON (B)(6) 2013. DUE TO TRAUMA (PERIPROSTHETIC SUBTROCHANTER FRACTURE WITH SUBSIDENCE OF THE FEMORAL STEM), THE PATIENT WAS REVISED ON (B)(6) 2013. IT WAS ALSO REPORTED THAT THE PATIENT HAD INCREASED PAIN IN HER RIGHT HIP FOR THE PREVIOUS THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312846 BIOLOX DELTA HEAD, 12/14, 32 X -3.5 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R