BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2213198 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14961
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 13, 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
    NY, 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

    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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    BILATERAL PATIENT - LITIGATION PAPERS ALLEGE IN OR AROUND APPROXIMATELY 2008, PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. ON OR AROUND (B)(6) 2011, PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY FOR HER LEFT HIP. APPROXIMATELY THREE TO SIX MONTHS AFTER REVISION OF HER LEFT HIP, PATIENT WILL BE SCHEDULED TO UNDERGO REVISION SURGERY FOR HER RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA 2433153

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention