BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM HEAD FEMRL ZIRCONIA 28+0

    MDR report key: 1040474 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01771
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    LZO
    PMA / PMN Number
    K921111
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODE REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISLOCATION (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM HEAD FEMRL ZIRCONIA 28+0 87LZO LZO DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention