BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 2151109 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11258
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    February 14, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2011-04120. THIS REPORT, 1818910-2011-11258, WILL BE REJECTED. 1818910-2011-04120 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    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. (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.

    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: PT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER RIGHT SIDE, ON OR ABOUT (B)(6), 2007. ON OR ABOUT (B)(6), 2010, PT SUFFERED CLICKING IN THE RIGHT HIP THAT COULD BE HEARD AND FELT; WHEN SHE MOVED FROM A SITTING TO A STANDING POSITION, SHE COULD FEEL A "VACUUM SOUND." SHE ALSO HAD HIP/GROIN PAIN THAT WOULD AWAKEN HER AT NIGHT AND THIS PAIN WAS PRESENT WHEN CLIMBING STEPS. AT TIMES, IT BECAME SEVERE, RADIATING INTO THE KNEE AND MAKING HER FEEL LIKE THE LEG WAS GOING TO COLLAPSE. SHE STATES THAT HER RIGHT LEG WAS ROTATED OUTWARD. ADDITIONALLY, PT'S BLOOD WORK HAS SHOWN EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PT HAD THE RIGHT ASR HIP IMPLANT EXPLANTED ON (B)(4), 2011. 6

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention