BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOW ROT HNG KNEE FME XL RGT

    MDR report key: 765660 · Received September 26, 2006

    Report

    Report Number
    9610726-2006-00051
    Event Type
    Injury
    Date Received
    September 26, 2006
    Date of Event
    September 7, 2006
    Report Date
    September 8, 2006
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON WAS REVISING THE IMPLANT BECAUSE THE PT HAD COMPLAINED OF KNEE PAIN. IT WAS DISCOVERED INTRAOPERATIVELY THAT THE IMPLANT HAD FRACTURED ACROSS THE CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOW ROT HNG KNEE FME XL RGT IMPLANT HSA STRYKER ORTHOPAEDICS LIMERICK NA LKRLC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention