BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 54

    MDR report key: 2792317 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-76857
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM METALLOSIS, INFLAMMATORY ARTHROPATHY, LYMPHOCYTIC RESPONSE, FIBROUS TISSUE AND PSEUDOMEMBRANE, LOOSENING OF THE PROSTHESIS, CHROMIUM AND COBALT TOXICITY, PAIN, DISFIGUREMENT AND MENTAL ANGUISH.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM METALLOSIS, INFLAMMATORY ARTHROPATHY, LYMPHOCYTIC RESPONSE, FIBROUS TISSUE AND PSEUDOMEMBRANE, LOOSENING OF THE PROSTHESIS, CHROMIUM AND COBALT TOXICITY, PAIN, DISFIGUREMENT AND MENTAL ANGUISH.**UPDATE** (B)(4) 2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 54 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2692789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other