BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - CUP

    MDR report key: 2071013 · Received April 20, 2011

    Report

    Report Number
    9616680-2011-00244
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    September 18, 2009
    Report Date
    April 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWB
    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 THAT, "THE REVISION WAS BECAUSE, THE IMPLANT STARTED CLICKING, WAS UNCOMFORTABLE, THEN BECAME PAINFUL AND GOT PROGRESSIVELY WORSE. SUMMER OF 2009, IT BECAME EXTREMELY PAINFUL. PRIMARY DOCTOR TOOK X-RAYS AND SAID, IT WAS NORMAL. PT BECAME BED RIDDEN BECAUSE OF EXTREME PAIN AND COULD NOT WALK. SHE WAS THEN TAKEN TO THE (B)(4). IT WAS DISCOVERED THAT THE CUP ROTATED 180 DEGREES. SHE WAS REVISED AND A NEW CUP WAS PUT IN ON (B)(6) 2009. SINCE THAT TIME, IT IS BETTER AND SHE CAN WALK ON IT BUT SHE IS FEELING OCCASIONAL PAIN WHEN SHE WALKS EXCESSIVELY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention