BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2060462 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05789
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 7, 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: REPORTING NUMBER. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, IMPLANT DATE, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT DEVELOPED PAINFUL AND DANGEROUS COMPLICATIONS, HAD TO UNDERGO AN UNNECESSARY AND PAINFUL REVISION SURGERY, HAS TO UNDERGO AN ADDITIONAL REVISION SURGERY, AND WILL HAVE LIFELONG RESIDUAL PROBLEMS. IT IS ALSO ALLEGED PATIENT SUFFERED ACETABULAR CUP DETACHMENT, DISCONNECTION, CREATION OF METALLIC DEBRIS AND/OR LOOSENING, PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY AND/OR OTHER INJURIES PRESENTLY UNDIAGNOSED. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, PATIENT DEVELOPED PAINFUL AND DANGEROUS COMPLICATIONS, HAD TO UNDERGO AN UNNECESSARY AND PAINFUL REVISION SURGERY, HAS TO UNDERGO AN ADDITIONAL REVISION SURGERY, AND WILL HAVE LIFELONG RESIDUAL PROBLEMS. IT IS ALSO ALLEGED PATIENT SUFFERED ACETABULAR CUP DETACHMENT, DISCONNECTION, CREATION OF METALLIC DEBRIS AND/OR LOOSENING, PAIN, INHIBITION OF THE ABILITY TO WALK, UNNECESSARY AND ADDITIONAL SURGERY AND/OR OTHER INJURIES PRESENTLY UNDIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2456923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention