BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR TIB BRG 79/83 X 12MM

    MDR report key: 3192961 · Received June 27, 2013

    Report

    Report Number
    3002806535-2013-00114
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6) 2010. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, DUE TO PAIN AND UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294469 VANGUARD CR TIB BRG 79/83 X 12MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 1788812

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R