BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 HI OFF

    MDR report key: 2914973 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00648
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    February 13, 2012
    Report Date
    December 28, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER LEG LENGTH DISCREPANCY RELATED REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM A NUMBER OF DIFFERENT COMPLAINTS INCLUDING PAIN, CLICKING OF THE IMPLANT COMPONENTS, AND CONSTANT DISCOMFORT. (B)(4) 2012 - PLAINTIFF FACT SHEET WAS RECEIVED. THE PRODUCT/LOT WAS UPDATED. (B)(4) 2012 - PATIENT'S OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THREADING AROUND THE TRUNNION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21867 SUMMIT POR TAPER SZ6 HI OFF STEM LPH DEPUY WARSAW C4VA71000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR