BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ6 HI OFF

    MDR report key: 2121230 · Received June 1, 2011

    Report

    Report Number
    1818910-2011-09569
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 2, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 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. 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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES WEAR FAILURE OF HEAD AND CUP. TROCHANTERIC BURSITIS, OSTEOLYSIS, CORROSION - LEADING TO REVISION OF SHELL AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT DUOFIX TAP SZ6 HI OFF 87 LPH, MEH LPH DEPUY ORTHOPAEDICS, INC. NA BC8A51000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention