BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA CERAMIC FEMORAL HEAD

    MDR report key: 3040293 · Received April 3, 2013

    Report

    Report Number
    9613350-2013-01464
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFIRMING. THE CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, THERE IS NO INDICATION FOR A PRODUCT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICES BE RETURNED FOR EVAL 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISLOCATION OCCURRED AND THE PT THEREFORE HAD TO UNDERGO A REVISION SURGERY DURING WHICH HEAD AND SHELL WERE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135887 BIOLOX DELTA CERAMIC FEMORAL HEAD BIOLOX DELTA HEAD, 12/14, 32 X -3.5 KXA ZIMMER GMBH 2603769

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R LOT# 2639327| ALLOFIT IT ALLOCLASSIC SHELL 50/HH, CAT# 008755050