BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1962418 · Received January 7, 2011

    Report

    Report Number
    1818910-2011-00130
    Event Type
    Injury
    Date Received
    January 7, 2011
    Report Date
    December 9, 2010
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    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.

    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. (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP 87KWA KWA DEPUY INTERNATIONAL LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention