BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER HEAD 40 12/14

    MDR report key: 4706223 · Received April 16, 2015

    Report

    Report Number
    9613350-2015-00441
    Event Type
    Injury
    Date Received
    April 16, 2015
    Date of Event
    March 11, 2015
    Report Date
    April 7, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THIS IS A SPLIT CASE WITH ZIMMER INC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA CER HEAD 40 12/14 ON (B)(6) , 2015. THE PATIENT WAS REVISED ON (B)(6) , 2015 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254732 BIOLOX DELTA CER HEAD 40 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2733049

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R