BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-OVER TIB BEAR COMP MRH TIBIA

    MDR report key: 2644635 · Received June 27, 2012

    Report

    Report Number
    9610726-2012-00217
    Event Type
    Injury
    Date Received
    June 27, 2012
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K002552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: GMRS TIBIAL INSERT SMALL 24MM, CAT #6495-3-024, LOT #LD164; DESCRIPTION: MRHK TIBIAL SLEEVE, CAT #6481-2-140, LOT #LAW297; DESCRIPTION: KRH DURATION BUSHING STANDARD, CAT #6485-2-460, LOT #LPTA469; DESCRIPTION: KRH DURATION STANDARD BUMPER, CAT #6485-4-100, LOT #LPTA475; DESCRIPTION: KRH STANDARD AXLE, CAT #6475-3-940, LOT #LCFYH. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAS A GMRS PROXIMAL TIBIA WITH A MRH FEMUR. SHE MIGHT BE INFECTED OR THE TUMOR HAS RECURRED. THE PLAN IS TO REMOVE ALL COMPONENTS OR REPLACE THE MRH FEMUR TO A GMRS DISTAL FEMUR. SURGERY ON (B)(6) 2012. PATHOLOGIST COULD NOT COME TO CONCLUSION. THE WOUND WAS WASHED AND CLOSED. NO IMPLANT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-OVER TIB BEAR COMP MRH TIBIA IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA P6AFC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention