BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINNED 1 PIECE TIBIAL TRAY

    MDR report key: 1812320 · Received August 16, 2010

    Report

    Report Number
    9610576-2010-00008
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOMET SPAIN S.L.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    NA
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6) 2008. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2010 TO CORRECT LIMITED RANGE OF MOTION AND INTERNAL ROTATION OF TIBIA COMPONENTS. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINNED 1 PIECE TIBIAL TRAY JWH BIOMET SPAIN S.L. NA 2007010099

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R