BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFINITION PM CEMENTED HIP #3

    MDR report key: 1910446 · Received November 23, 2010

    Report

    Report Number
    9616680-2010-00776
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K936127
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD A CEMENTED SIZE 3 DEFINITION HIP STEM, 54 MM VITALOCK CUP 0 DEGREE LINER WITH 28 MM HEAD IMPLANTED ABOUT 12 YEARS AGO. THERE WAS SIGNIFICANT OSTEOLYSIS AROUND FEMORAL COMPONENT PROXIMALLY AND THE STEM HAD MIGRATED TO A VARUS POSITION. THE STEM WAS EXTRACTED FROM THE CANAL WITH LITTLE TO NO FORCE BEFORE THE ETO. THE STEM HAD NO RESIDUAL BONE CEMENT ATTACHED TO STEM. THERE WAS A COMPLETE DEBONDING BETWEEN STEM AND BONE CEMENT. THE POLY INSERT SHOWED VERY LITTLE WEAR. THE OSTEOLOCK CUP WAS IN GOOD ALIGNMENT AND WELL FIXED, IT DID NOT NEED TO BE REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFINITION PM CEMENTED HIP #3 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA C8RZA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R