BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP MAGNUM SHELL

    MDR report key: 1893172 · Received October 29, 2010

    Report

    Report Number
    3002806535-2010-00090
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 1, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    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. THE (B)(6) IS HOLDING THE PRODUCT AND HAS PERFORMED AN EVAL ON THE RETURNED EXPLANT. REPORT RECEIVED FROM (B)(6) INDICATED THE CAUSE OF THE FAILURE WAS "UNEXPLAINED". THIS REPORT FILED (B)(4), 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE (B)(6) THAT PT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2008. PT UNDERWENT REVISION SURGERY ON (B)(6), 2010, DUE TO UNK REASONS. 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 1567161

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R