BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3151075 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-18358
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 20, 2013
    Report Date
    August 15, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, STIFFNESS, DISCOMFORT, AND WEAKNESS. ALSO ALLEGED IS DIFFICULTY AMBULATING AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PART/LOT WERE IDENTIFIED. DOI RECEIVED. THE COMPLAINT AND ASSOCIATED MDR'S WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO SUSPECTED CUP LOOSENING AND OSTEOLYSIS. FOLLOW UP WAS DONE TO CONFIRM LOOSENING, REP STATED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249813 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTL., LTD. - 8010379 2397173

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention