BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3010149 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01024
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED X-RAYS AND OFFICE NOTE WERE REJECTED FOR MEDICAL REVIEW. THERE WAS NO CONFIRMATION OF THE REPORTED LOOSENING BASED ON THE XRAYS PROVIDED. THE EVENT COULD NOT BE CONFIRMED. AND THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. THERE WAS NO CONFIRMATION OF THE REPORTED LOOSENING BASED ON THE XRAYS PROVIDED. ADDITIONAL INFORMATION IS NEEDED INCLUDING CLINICAL HISTORY, OPERATIVE REPORTS, AND EXAMINATION OF EXPLANTED COMPONENTS.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN #11 TRAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEONS OFFICE COMPLAINING OF PAIN IN THE KNEE. FELL ON VACATION AND FEELS LAXITY IN KNEE WHEN LYING DOWN. REVISION SURGERY AFTER SEEING LOOSENING ON X-RAYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEONS OFFICE COMPLAINING OF PAIN IN THE KNEE. FELL ON VACATION AND FEELS LAXITY IN KNEE WHEN LYING DOWN. REVISION SURGERY AFTER SEEING LOOSENING ON X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114036 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention