BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL WITH PUREFIX HA

    MDR report key: 2149082 · Received June 24, 2011

    Report

    Report Number
    2249697-2011-00956
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICES ARE STILL IMPLANTED IN THE PATIENT. A MEDICAL AUTHORIZATION WAS SENT TO THE PATIENT IN AN ATTEMPT TO RETRIEVE THE MEDICAL RECORDS FOR REVIEW. IF ADDITIONAL INFORMATION IS PROVIDED, THE RECORDS WILL BE REVIEWED BY A CLINICAL CONSULTANT AND THE RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ASSOCIATE DEVICES: SECUR-FIT MAX, CAT # 6052-1340S, LOT # MHA009 AND C-TAPER COCR LFIT HEAD 36MM/+10, CAT # 06-3610, LOT # UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) 2011 DISLOCATION OSU MAIN ER. THE PATIENT WAS TOLD THAT IT WAS VERY DIFFICULT TO FIX. PATIENT CANNOT WALK VERY FAR WITHOUT PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL WITH PUREFIX HA IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 9W7MKD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention