BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC OPTION CUP 48MM

    MDR report key: 2111612 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08473
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITH THE PROVIDED INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS IMPINGEMENT OF THE FEMORAL NECK PORTION OF THE HEAD WITH THE ACETABULAR SHELL. THE ACETABULAR COMPONENT WAS IMPLANTED WITH TOO MUCH ANTEVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC OPTION CUP 48MM 87MRA MRA DEPUY INTERNATIONAL, LTD. NA 1895717

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention