BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3093552 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01559
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    October 1, 2011
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND SWELLING INVOLVING AN UNKNOWN KNEE SYSTEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SWELLING IN HIS LEFT KNEE. PATIENT STATES THAT WHEN HIS KNEE IS SWOLLEN, HE IS UNABLE TO BEND HIS KNEE. PATIENT IS ALSO EXPERIENCING PAIN IN THE KNEE. PATIENT STATES THAT PAIN AND SWELLING STARTED ABOUT (B)(6) 2011. PATIENT STATES THAT HE HAD ARTHROSCOPIC SURGERY ON HIS KNEE. PATIENT IS CURRENTLY SEEING DR (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS SWELLING IN HIS LEFT KNEE. PATIENT STATES THAT WHEN HIS KNEE IS SWOLLEN HE IS UNABLE TO BEND HIS KNEE. PATIENT IS ALSO EXPERIENCING PAIN IN THE KNEE. PATIENT STATES THAT PAIN AND SWELLING STARTED ABOUT (B)(6) 2011. PATIENT STATES THAT HE HAD ARTHROSCOPIC SURGERY ON HIS KNEE. PATIENT IS CURRENTLY SEEING DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196902 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention