BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT STRYKER KNEE

    MDR report key: 2821546 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-01999
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    December 19, 2007
    Report Date
    October 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAS HAD DISCOMFORT IN HER LEFT KNEE SINCE SHE RECEIVED THE IMPLANT. SHE COMPLAINED TO HER SURGEON DURING HER SIX-WEEK CHECKUP AND WAS TOLD IT WOULD GO AWAY IN TIME. THE PROBLEM HAS NEVER SUBSIDED. THE PT HAS A BURNING SENSATION LIKE PINS AND NEEDLES AROUND THE KNEE CAP. SHE SAYS SOMETIMES IT FEELS LIKE A BLOW TORCH IS IN HER KNEE. SHE REGULARLY EXPERIENCES LOUD POPPING CRACKING IN HER KNEE WHEN SHE STRAIGHTENS LEG OR STANDS UP FROM A SEATED POSITION. SHE EXPERIENCES PAIN IN HER KNEE DURING INCLEMENT WEATHER. THE PT HAS BILATERAL KNEE IMPLANTS. SHE HAS THE SAME EXPERIENCE IN BOTH KNEES; HOWEVER THE PROBLEMS WITH THE RIGHT KNEE ARE MORE INTENSE THAN THE LEFT. THE PT STATES THAT BOTH IMPLANTS ARE STRYKER BUT DOES NOT KNOW IF THEY ARE PART OF THE RECALL. THE PT WILL FAX HER IMPLANT SHEETS TO THE REGULATORY DEPARTMENT TO DETERMINE THE RECALL STATUS OF HER IMPLANTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other