BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3864159 · Received June 10, 2014

    Report

    Report Number
    0002249697-2014-02164
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 66 INCHES IN HEIGHT. AN EVENT REGARDING A RECURRENT DISLOCATION INVOLVING AN UNKNOWN KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN KNEE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REPORTER'S MOTHER HAD A KNEE REPLACEMENT IN (B)(6) 2006. FOR THE LAST THREE MONTHS HER RIGHT KNEE HAD DISLOCATED FOUR TIMES. DOCTORS ARE SAYING THAT NOW HER KNEE NEEDS SPACER.

    Description of Event or Problem · 1

    THE REPORTER'S MOTHER HAD A KNEE REPLACEMENT IN (B)(6) 2006. FOR THE LAST THREE MONTHS HER RIGHT KNEE HAD DISLOCATED FOUR TIMES. DOCTORS ARE SAYING THAT NOW HER KNEE NEEDS SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337783 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other