BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC DIA56/50MM

    MDR report key: 5922929 · Received September 1, 2016

    Report

    Report Number
    3002806535-2016-00700
    Event Type
    Injury
    Date Received
    September 1, 2016
    Date of Event
    November 15, 2013
    Report Date
    August 3, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). PMA 510(K) - THIS DEVICE IS NOT MANUFACTURED OR MARKETED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS A SIMILAR DEVICE IS MANUFACTURED AT ZIMMER BIOMET IN THE UNITED STATES UNDER 510(K) K042037. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS IS 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3002806535-2016-00699 & 00700). NOT RETURNED BY ATTORNEY.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT WAS REVISED APPROXIMATELY 7 YEARS POST-IMPLANTATION ALLEGEDLY DUE TO PAIN, ELEVATED METAL ION LEVELS AND AUDIBLE NOISE IN THE JOINT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573973 RECAP SHELL COCR PC DIA56/50MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 909933

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R