BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ6 HI OFF

    MDR report key: 1964161 · Received January 6, 2011

    Report

    Report Number
    1818910-2010-10688
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 21, 2010
    Report Date
    December 7, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REPORTS: PATIENT RECEIVED AN ASR XL/SUMMIT PRIMARY HIP ON (B)(6) 2010 BUT WAS NEVER REALLY HAPPY WITH RESULT. PATIENT PRESENTED WITH AN ONGOING UNEXPLAINED PAIN. AT THE TIME OF SURGERY, TISSUES WERE STAINED; METALLOSIS. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS REGARDING THE ASR PRODUCT FAMILY WILL BE DOCUMENTED, AS DETERMINED PERTINENT, IN (B)(4). BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME.

    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

    THE PT WAS REVISED TO ADDRESS PAIN AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT DUOFIX TAP SZ6 HI OFF 87LPH, MEH LPH DEPUY ORTHOPAEDICS, INC. NA X2SFH1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention