BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2113058 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08319
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS ALLEGE THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENTS ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PATIENTS ABILITY TO WALK, AND WILL REQUIRE A REVISION SURGERY. DOI: (B)(6) 2006 - DOR: NO REVISION REPORTED AT THIS TIME. (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(4) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. PATIENT WAS REVISED, REASON NOT PROVIDED. THE PART/LOT FOR THE FEMORAL HEAD WAS IDENTIFIED AND ADDED TO THE COMPLAINT. DOR: (B)(6) 2011. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PT'S ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PT'S ABILITY TO WALK, AND WILL REQUIRE A REVISION SURGERY. THE SALES REP REPORTED THE REVISION SURGERY. PT WAS REVISED, REASON NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2192256

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention