BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 3093000 · Received May 3, 2013

    Report

    Report Number
    1818910-2013-05443
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 12, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 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. REF. (B)(4).

    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 DUE TO PAIN, CLUNKING IN HIS HIP, ELEVATED METAL ION LEVELS, OSTEOLYSIS, SALES REP NOTED THAT THE CUP APPEARED TO HAVE MOVED FROM THE ORIGINAL POSITION BUT IT WAS NOT LOOSE AT THE TIME OF REVISION. UPDATE LITIGATION ALLEGED THE ASR HIP WAS EXPLANTED DUE TO PAIN, GRINDING, CLICKING, POPPING, DIFFICULTY WALKING, INFECTION, DISABILITY, DISFIGUREMENT AND ELEVATED BLOOD LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193667 SUMMIT POR TAPER SZ7 HI OFF FEMORAL STEM HIP IMPLANT LPH DEPUY WARSAW AF7GK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention