BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3093920 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01564
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    January 1, 2007
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN AND HYPEREXTENSION OF THE KNEE INVOLVING AN UNKNOWN KNEE IMPLANT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING HYPER EXTENSION TO HER KNEE. PATIENT STATES THAT IT STARTED DURING PHYSICAL THERAPY AFTER KNEE IMPLANT SURGERY. PATIENT WANTS TO KNOW IF IT IS GOING TO GET MORE HYPER EXTENDED IN THE FUTURE. PATIENT ALSO NOTES THAT SHE HAS PAINFUL DAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING HYPER EXTENSION TO HER KNEE. PATIENT STATES THAT IT STARTED DURING PHYSICAL THERAPY AFTER KNEE IMPLANT SURGERY. PATIENT WANTS TO KNOW IF IT IS GOING TO GET MORE HYPER EXTENDED IN THE FUTURE. PATIENT ALSO NOTES THAT SHE HAS PAINFUL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196105 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention