BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MET ENCAP INSERT DURATION SML

    MDR report key: 2132583 · Received June 10, 2011

    Report

    Report Number
    9610726-2011-00203
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K972863
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT WAS COMPLAINING OF "WOBBLE." THERE WASN'T ANY WEAR PRESENT. THE DOCTOR WAS INVESTIGATING A MASS AND DECIDED TO PERFORM A POLY SWAP. THE SURGEON FEELS THAT THE MEDIAL SIDE WAS NOT FLUSH WITH THE BASEPLATE ON EITHER POLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MET ENCAP INSERT DURATION SML IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LPTB779

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention