BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA TAPER LINER, LL/40

    MDR report key: 2090937 · Received May 2, 2011

    Report

    Report Number
    9613350-2011-00284
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN (B)(4). THE MANUFACTURER DID NOT YET 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. AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED WHEN FURTHER INFO OR THE INVESTIGATION RESULT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT HIP CERAMIC LINER HAS DISLOCATED FROM SHELL. PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX DELTA TAPER LINER, LL/40 HIP CERAMIC LINER LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization