BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ASR HIP

    MDR report key: 1895014 · Received November 5, 2010

    Report

    Report Number
    1818910-2010-08412
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    June 3, 2010
    Report Date
    October 6, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SPECIFIC REASON FOR THE PT'S REVISION IS UNK, BECAUSE THE PT'S CLAIM HAS BEEN APPROVED BY DEPUY-S THIRD-PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE REASON FOR THE REVISION HAS BEEN DETERMINED TO BE PRODUCT-RELATED. 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

    PT CONTACTED (B)(6) TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention