BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 32 X 0

    MDR report key: 3060190 · Received April 11, 2013

    Report

    Report Number
    9613350-2013-01485
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 23, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A BIOLOX DELTA HEAD, (B)(6), 32 X 0 AN (B)(4) 2011 AND UNDERWENT REVISION SURGERY ON (B)(6) 2013 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156157 BIOLOX DELTA HEAD, 12/14, 32 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH 2597816

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R