BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC V2 INTERLOK TIB 10X 79MM

    MDR report key: 4111322 · Received September 23, 2014

    Report

    Report Number
    3002806535-2014-00207
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS 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 KNEE SURGERY ON (B)(6), 2004. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO TIBIAL LOOSENING. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590287 AGC V2 INTERLOK TIB 10X 79MM PROSTHESIS, KNEE JWH BIOMET UK LTD. N/A 668824

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R