BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 32 X 0

    MDR report key: 1902495 · Received November 11, 2010

    Report

    Report Number
    9613350-2010-00512
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER 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 CONFORMING. IT IS NOT SUSPECTED THAT THE ALLEGED EVENT HAS BEEN CAUSED BY DEVICE FAILURE. 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 FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY, DUE TO INSTABILITY AND SUSPECTED LOOSENING OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA HEAD, 12/14, 32 X 0 CERAMIC FEMORAL HEAD LZO ZIMMER GMBH NA 2548230

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization