BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 56MM

    MDR report key: 1020266 · Received March 25, 2008

    Report

    Report Number
    1818910-2008-00839
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    P070026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 56MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA CA3FT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention