BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 28 X +3.5

    MDR report key: 3760802 · Received April 9, 2014

    Report

    Report Number
    9613350-2014-03431
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    November 9, 2011
    Report Date
    March 11, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE AFFECTED DEVICES, AND X-RAYS, ALTHOUGH THE SURGICAL REPORTS WERE RECEIVED. THESE DOCUMENTS WILL BE EVALUATED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE CAUSE OF THIS EVENT CANNOT BE ASCERTAINED FROM THE INFO RECEIVED, BUT ONCE THE PRODUCTS ARE RECEIVED AND INVESTIGATED AND THE REPORT BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY, THE PT UNDERWENT SURGERY AND WAS IMPLANTED WITH A BILOX DELTA HEAD 12/14, 28 X +3.5, ON HER RIGHT HIP. THE ACETABULAR COMPONENT HAS LOOSENED AND IT HAD SUBSIDED INTO THE BONE. ON(B)(6) 2011, THE PT UNDERWENT SECOND REVISION SURGERY DUE TO GROWING PAIN IN THE AREA OF HER GROIN. THE HEAD AND THE CUP WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212942 BIOLOX DELTA HEAD, 12/14, 28 X +3.5 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2429002

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R