BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA TOTAL KNEE TIB COMP LARGE

    MDR report key: 2161167 · Received July 8, 2011

    Report

    Report Number
    2249697-2011-01033
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K802922
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT PRESENTED TO THE DOCTOR APPROX 3 MONTHS AGO WITH KNEE PAIN. X-RAYS REVEALED COMPLETE MEDIAL COMPARTMENT LOSS AND THE SUNRISE VIEW SHOWED THAT THE BASEPLATE WAS BROKEN, SO THE SURGEON REVISED." THE EXACT IMPLANTATION DATE WAS NOT PROVIDED, HOWEVER IT WAS INDICATED THAT THE REPORTED DEVICES WERE IMPLANTED APPROXIMATELY IN 1992.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA TOTAL KNEE TIB COMP LARGE IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA OOSCAA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention