BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SECURFIT STEM

    MDR report key: 2912772 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90050
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID A LEFT HIP REVISION CAUSED A PERI PROSTHETIC FRACTURE AS A RESULT OF A FALL WHICH CAUSED THE FEMUR TO BREAK AROUND THE ORIGINAL SECUR FIT STEM CAUSING THE STEM TO BECOME LOOSE AS A RESULT OF THE FRACTURE FROM THE PT FALLING DOWN. SURGEON REVISED WITH A RESTORATION CONE CONICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8227 UNK SECURFIT STEM IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R