BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC POR SHELL/MULTIHOLE SZ54MM

    MDR report key: 1222443 · Received November 4, 2008

    Report

    Report Number
    1818910-2008-05155
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K930712
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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. THE INVESTIGATION COULD NOT 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 LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC POR SHELL/MULTIHOLE SZ54MM 87HDL JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention