BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CUP

    MDR report key: 1801226 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05443
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE KNOWN PRODUCT/LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. PRODUCT/LOT INFORMATION WAS NOT PROVIDED FOR THE ASSOCIATED CUP. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. OSTEOLYSIS WAS DISCOVERED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY CUP TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention