BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2111384 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08179
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE AND UNRELENTING PAIN AND DISCOMFORT IN HER THIGH, GROIN, HIP-JOINT, BACK, AND RIGHT BUTTOCK, A CLICKING, POPPING, AND LOCKING-UP SENSATION IN HER HIP-JOINT WHEN SHE WALKS OR OTHERWISE MOVES, SEVERE PAIN WHEN MOVING FROM SITTING TO STANDING POSITION, INABILITY TO STAND FOR MORE THAN APPROXIMATELY FIVE MINUTES WITHOUT HAVING TO SIT DOWN, INABILITY TO USE STAIRS, SWELLING AND INFLAMMATION, METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANT, A LACK OF MOBILITY, CHROMIUM AND COBALT METAL TOXICITY, AND AN ABILITY TO PERFORM NORMAL DAILY LIVING TASKS. DOI: (B)(6) 2007 - DOR: N/I (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. 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 PT SUFFERED SYMPTOMS DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE AND UNRELENTING PAIN AND DISCOMFORT IN HER THIGH, GROIN, HIP-JOINT, BACK, AND RIGHT BUTTOCK, A CLICKING, POPPING, AND "LOCKING-UP" SENSATION IN HER HIP-JOINT WHEN SHE WALKS OR OTHERWISE MOVES, SEVERE PAIN WHEN MOVING FROM SITTING TO STANDING POSITION, INABILITY TO STAND FOR MORE THAN APPROXIMATELY FIVE MINUTES WITHOUT HAVING TO SIT DOWN, INABILITY TO USE STAIRS, SWELLING AND INFLAMMATION, METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANT, A LACK OF MOBILITY, CHROMIUM AND COBALT METAL TOXICITY, AND AN ABILITY TO PERFORM NORMAL DAILY LIVING TASKS. THE SALES REP REPORTED THE REVISION SURGERY. THE PT WAS REVISED TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2317061

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention