BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SUMMIT FEMORAL STEM

    MDR report key: 2142850 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11223
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 1, 2008
    Report Date
    January 11, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LWJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT DID NOT HAVE A FEMORAL STEM, THIS WAS REPORTED IN ERROR.

    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

    LITIGATION PAPERS ALLEGE, THE FEMORAL COMPONENT OF PT'S ASR HIP BEGAN TO LOOSEN AND ON (B)(6) 2008, A LEFT HIP REVISION SURGERY WAS PERFORMED. IT IS ALSO ALLEGED, PT HAS SUFFERED AND CONTINUES TO SUFFER SERIOUS AND PERMANENT NON-ECONOMIC AND ECONOMIC INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SUMMIT FEMORAL STEM TOTAL HIP REPLACEMENT LWJ DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention