BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2202344 · Received August 8, 2011

    Report

    Report Number
    1818910-2011-15302
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 31, 2011
    Report Date
    July 13, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    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 (B)(6) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE ON OR ABOUT (B)(6) 2009. SOME TIME AFTER IMPLANTATION, PT BEGAN EXPERIENCING PAIN, NUMBNESS, AND LOSS OF MOBILITY. PT HAD THE LEFT ASR HIP REVISED ON (B)(6) 2011. UPDATE (B)(6) 2011 - MEDICAL RECORDS RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT A SMALL AMOUNT OF SEROUS FLUID WAS NOTICED INTRAOPERATIVELY. ADDITIONALLY, THERE WAS FAILURE OF IN-GROWTH OF THE ACETABULAR COMPONENT. PART/LOT NUMBERS IDENTIFIED WITH INVOICE SEARCH. NO NEW INFO WAS RECEIVED THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2859593

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention