BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 28MM SYSTEM 12 INSERT 10 DEGREE HOOD

    MDR report key: 2161165 · Received July 8, 2011

    Report

    Report Number
    9616680-2011-00461
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT EXPERIENCED PAIN AND IT WAS FOUND THAT SHE WAS DISLOCATED SO THE SURGEON REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 28MM SYSTEM 12 INSERT 10 DEGREE HOOD IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention