BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN POLY BEARING

    MDR report key: 3101305 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01321
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2007. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO INSTABILITY. THE BEARING WAS REMOVED AND REPLACED WITH A LARGER BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203551 UNKNOWN POLY BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R