BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANATOMIC BEARING

    MDR report key: 1940501 · Received December 21, 2010

    Report

    Report Number
    3002806535-2010-00108
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    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 INFO 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 KNEE PROCEDURE ON (B)(6) 2009. PT UNDERWENT REVISION SURGERY ON (B)(6) 2010, DUE TO INFECTION (SYNOVITIS). NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXFORD ANATOMIC BEARING NRA BIOMET UK LTD. NA 1633406

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R