BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX

    MDR report key: 1915767 · Received November 29, 2010

    Report

    Report Number
    2249697-2010-01634
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    February 8, 2010
    Report Date
    November 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K041170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT HAD A HIP REPLACEMENT ON (B)(6) 2010. SHE HAS BEEN EXPERIENCING INFECTION AND SEVERE PAIN. PT IS ASKING IF THIS IMPLANT WAS PART OF ANY RECALL. HAS HAD A FOLLOW UP SURGERY TO TRY AND CLEAR UP THE INFECTION, BUT DID NOT REMOVE THE IMPLANT AS OF YET."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R