BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HEAD, 12/14, 36 X 0

    MDR report key: 1842847 · Received September 16, 2010

    Report

    Report Number
    9613350-2010-00451
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    June 21, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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 EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. BASED ON THE PROVIDED INFO, THE EXACT CAUSE OF THE COMPLAINT OR DEVICE FAILURE CANNOT BE CONCLUSIVELY DETERMINED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSEMENT, 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 CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CUP LINER AND BIOLOX HEAD WERE REMOVED AND REPLACED WITH A NEW LINER AND HEAD DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA HEAD, 12/14, 36 X 0 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH NA 2475565

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R