BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3113401 · Received May 15, 2013

    Report

    Report Number
    0002249697-2013-01678
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INCISION SITE OPENED UP AND FLUID DISCHARGED INVOLVING A UNKNOWN KNEE IMPLANT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND SWELLING IN HER RIGHT KNEE. PATIENT IS ALSO REPORTING THAT HER RIGHT KNEE IS DARKER IN COLOR THAN HER LEFT KNEE. PATIENT STATES THAT THE INCISION SITE OPENED UP AND FLUID DISCHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND SWELLING IN HER RIGHT KNEE. PATIENT IS ALSO REPORTING THAT HER RIGHT KNEE IS DARKER IN COLOR THAN HER LEFT KNEE. PATIENT STATES THAT THE INCISION SITE OPENED UP AND FLUID DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214071 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention