BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA ACE/LOW PROFILE SHELL 49MM

    MDR report key: 2032667 · Received March 17, 2011

    Report

    Report Number
    2249697-2011-00327
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K852153
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MED RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PT CAME TO OFFICE STATING HAD PAIN IN LEFT HIP UPON X-RAY. A LYTIC LESION BEHIND CUP DOME WITH CUP POSITION SHIFTED HORIZONTALLY PLAN TO PROCEED WITH HIP REVISION. CUP CAME OUT EASILY STEM DID BUT SLEEVE WAS LEFT IN FEMUR. CHOICE WAS TO LEAVE IN AFTER SEVERAL ATTEMPTS TO EXTRACT TRITANIUM CUP ACCOLADE C-STEM PUT IN AS REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA ACE/LOW PROFILE SHELL 49MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA NIGXA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R