BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2122762 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09585
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    June 1, 2008
    Report Date
    May 5, 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 Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT CONTACTED (B)(4) TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. **UPDATE** (B)(6) 2011 - LITIGATION PAPERS RECEIVED. LITIGATION PAPERS ALLEGE THE PATIENT WILL LIKELY UNDERGO A SECOND REVISION SURGERY, AND MAY DEVELOP HIGH CONCENTRATIONS OF METAL IONS IN HER BLOOD. DOI: (B)(6) 2008 - NO REPORTED REVISION AT THIS TIME (RIGHT SIDE). **UPDATE** (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. 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

    PATIENT CONTACTED BROADSPIRE TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. UPDATE (B)(6) 2011 - LITIGATION PAPERS RECEIVED. LITIGATION PAPERS ALLEGE THE PATIENT WILL LIKELY UNDERGO A SECOND REVISION SURGERY, AND MAY DEVELOP HIGH CONCENTRATIONS OF METAL IONS IN HER BLOOD. UPDATE (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2571887

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention