BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGV V2 INTERLOK TIBIAL

    MDR report key: 2023215 · Received March 15, 2011

    Report

    Report Number
    3002806535-2011-00028
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    K921182
    Removal / Correction Number
    NA
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE PROCEDURE ON (B)(6), 2007. PATIENT HAD REVISION SURGERY ON (B)(6), 2011 DUE TO PAIN AND INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGV V2 INTERLOK TIBIAL JWH BIOMET UK LTD. NA 1296790

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R