BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM SHELL WITH MULTI HOLES

    MDR report key: 2875141 · Received December 12, 2012

    Report

    Report Number
    1822565-2012-02521
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS NOTED THAT THE SHELL WAS LOOSE AND SCREWS WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM SHELL WITH MULTI HOLES LZO ZIMMER INC 61629577

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention VERSYS FEMORAL HEAD: CATALOG #00801802803| BONE SCREW: CATALOG #00625006540| LINER: CATALOG # 00875800928, LOT # UNK| THE FOLLOWING WERE MANUFACTURED BY ZIMMER| LOT #61504866| LOT #60103090| LOT #60970328| CONTINUUM, TRILOGY IT, ALLOFIT IT POLY CONSTRAINED| (B)(4)| HGP II BONE SCREW, CATALOG # 00662406520,| HGP BONE SCREW: CATALOG #00662406525| LOT #61560488| HGP II BONE SCREW: CATALOG #00662406530| LOT #61830573| HGP II BONE SCREW: CATALOG #00662406525| LOT #61674476