BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3827928 · Received May 22, 2014

    Report

    Report Number
    0001825034-2014-04643
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    September 25, 2009
    Report Date
    January 28, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MEDWATCH IS BEING SUBMITTED TO REPORT THAT THIS MEDWATCH IS A DUPLICATE OF (B)(4), 1825034-2013-02830. THIS MEDWATCH 1825034-2014-04643 IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. LEGAL COUNSEL REPORTED PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS PAIN, LOSS OF MOBILITY, METALLOSIS, AND LOSS OF RANGE OF MOTION. 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
    304691 UNKNOWN PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R