BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 50/44MM

    MDR report key: 2842584 · Received November 21, 2012

    Report

    Report Number
    3002806535-2012-00356
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. THERE HAS BEEN NO REVISION PROCEDURE PERFORMED TO DATE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A WRITTEN LIABILITY CLAIM FROM PATIENT'S ATTORNEY THAT PATIENT UNDERWENT PRIMARY TOTAL HIP ARTHROPLASTY ON (B)(6), 2007. CLAIM ALLEGES THAT DUE TO UNDEFINED PATIENT COMPLAINTS, ADDITIONAL EXAMS ARE NEEDED AND THERE ARE CONCERNS OF A POSSIBLE PSEUDOTUMOR. NO REVISION PROCEDURE HAS BEEN PERFORMED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECAP SHELL COCR PC 50/44MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1213620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R