BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 X3 INSERT 32MM ID

    MDR report key: 1893409 · Received November 4, 2010

    Report

    Report Number
    2249697-2010-01470
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    August 13, 2009
    Report Date
    October 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY (B)(4) . NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THIS PATIENT IS ENROLLED IN (B)(4) . THE SITE REPORTED ON A CRF THAT THE PATIENT EXPERIENCED A DISLOCATION POST-OP. THE SITE DID NOT CONSIDER THIS EVENT TO BE RELATED TO THE DEVICE AND ALSO NOTED THAT IT MAY HAVE BEEN RELATED TO PHYSICAL THERAPY. THE PATIENT WAS TREATED WITH CLOSED REDUCTION AND HIP BRACING AND THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2007. THIS EVENT WAS DISCOVERED DURING A REVIEW OF DATA REPORTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA PMPMMD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R