BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 56

    MDR report key: 2060532 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05694
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: REPORTING NUMBER. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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 PT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, SEVERE PAIN AND SUFFERING AND INCONVENIENCE, LOST WAGES, LOSS OF FUTURE EARNING CAPACITY, MEDICAL EXPENSES AND THE LIKELIHOOD OF FUTURE MEDICAL EXPENSES. IT IS ALSO ALLEGED PT WILL LIKELY UNDERGO MULTIPLE REVISION SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 56 ACETABULAR SHELL KWA DEPUY INTL. LTD. NA 2773088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention