BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - LEFT KNEE

    MDR report key: 1881166 · Received October 20, 2010

    Report

    Report Number
    9610726-2010-00373
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PRIMARY LEFT KNEE. PT INDICATED THAT HE IS CURRENTLY EXPERIENCING PAIN AND THAT THE KNEE BUCKLES. DOCTOR INFORMED HIM THAT HE NEEDS TO BE REVISED, HOWEVER, HIS RIGHT KNEE IS NOT STRONG ENOUGH TO SUPPORT THE LEFT REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - LEFT KNEE IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other