BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX

    MDR report key: 1910426 · Received November 23, 2010

    Report

    Report Number
    2249697-2010-01611
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    July 15, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K041170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADD'L INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT REPORTED THAT SHE IS EXPERIENCING PAIN. LEFT HIP SURGERY. SHE HAS BEEN TOLD THAT ONE LEG, THE LEFT THAT HAS THE IMPLANT IS NOW LONGER. PT IS TRYING TO OBTAIN ANSWERS FROM THE HOSPITAL AND DR. THE DR WENT ON MEDICAL LEAVE AFTER SURGERY AND HAS BEEN UNAVAILABLE TO THE PT SINCE IMMEDIATELY AFTER THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIT MAX IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJHDLJ

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R