BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2252597 · Received September 18, 2011

    Report

    Report Number
    1818910-2011-18401
    Event Type
    Injury
    Date Received
    September 18, 2011
    Report Date
    August 26, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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

    UPDATE: (B)(6) 2012 PATIENT FACT SHEET FORM WAS RECEIVED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: AFTER THE IMPLANT OF THE DEVICE, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT; PRODUCT HAS INTRODUCED UNHEALTHY AND/OR TOXIC LEVELS OF HEAVY METALS, INCLUDING BUT NOT LIMITED TO COBALT AND CHROMIUM, INTO PATIENTS TISSUES, BLOOD, AND OTHER PARTS OF PATIENTS BODY. PATIENT CANNOT AMBULATE WITHOUT ASSISTANCE. **UPDATE** (B)(6) 2011 - THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. ADDITIONALLY IT WAS NOTED THAT THE PATIENT IS BILATERAL. **UPDATE** (B)(6) 2011 - MEDICAL RECORDS WERE RECEIVED. PART/LOT NUMBERS WERE IDENTIFIED WITH INVOICE SEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2277364

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention