BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT

    MDR report key: 2120377 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00364
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    December 10, 2008
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AN ADVERSE EVENT WAS REPORTED FOR PATIENT NO 5 IN THE (B)(6) STUDY AT (B)(6). THE SURGEON (B)(6) REPORTED TO CRM (B)(4) THAT THE PATIENT EXPERIENCED HIP DISLOCATION 2008-(B)(6) THAT WAS SOLVED WITH CLOSED REDUCTION. HE FURTHER REPORTS THAT THERE WERE RECURRENT DISLOCATIONS LEADING TO REVISION 2008-(B)(6) WHERE THE LINER AND HEAD WAS REPLACED. DUE TO THE REVISION, THE PATIENT WAS TERMINATED FROM THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention