BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP MAGNUM SHELL

    MDR report key: 1940503 · Received December 21, 2010

    Report

    Report Number
    3002806535-2010-00106
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 25, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    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 PRIMARY KNEE PROCEDURE ON (B)(6) 2005. PT UNDERWENT REVISION SURGERY ON (B)(6) 2010 DUE TO METAL DEBRIS. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECAP MAGNUM SHELL KWA BIOMET UK LTD. NA 798388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R