BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 1770363 · Received July 20, 2010

    Report

    Report Number
    1818910-2010-04680
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FEMORAL STEM. 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 CUP LOOSENING SECONDARY TO IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 87KWA KWA DEPUY INTERNATIONAL LTD. NA 1831565

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention