BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3162538 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18608
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    November 21, 2011
    Report Date
    May 13, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE ACETABULAR CUP EVENTUALLY DETERIORATED, DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, LOOSENED FROM PATIENT'S ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PATIENT'S ABILITY TO WALK, AND/OR OTHERWISE CAUSED PATIENT TO LIVE IN FEAR OF DEVELOPING FUTURE DISEASES AND MEDICAL CONDITIONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2011 (LEFT HIP). REVISION HIP ADDITIONALLY LOOSENED AND REQUIRED REVISION; HOWEVER, IT IS UNKNOWN IF THESE DEVICES WERE MANUFACTURED BY DEPUY. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). *PATIENT IS A RESIDENT OF (B)(6). **UPDATE** (B)(4) 2013 - ASR/SUPPLEMENTAL INFORMATION RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262647 ASR UNI FEMORAL IMPL SIZE 51 TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. ¿ REG. # 8010379 2471267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other