BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP MAGNUM SHELL

    MDR report key: 2201789 · Received August 5, 2011

    Report

    Report Number
    3002806535-2011-00124
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    February 16, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. EXPIRATION DATE - UNK. THIS IS 2 OF 3 MDRS RELATING TO THE SAME REPORTED EVENT. PLEASE ALSO SEE MDRS 3002806535-2011-00123 AND 3002806535-2011-00125. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    LEGAL CLAIM STATES THAT PT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6), 2008. REVISION SURGERY WAS PERFORMED ON (B)(6), 2011 DUE TO THE BASIS OF TEST CONDUCTED AT THE (B)(6). 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R