BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2961689 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00674
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 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

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. 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, THE RESULTS OF THE INVESITGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN DURACON LINER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER - HOSPITAL POLICY

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD WORN POLY IN 17 YEAR OLD KNEE. SURGEON EXPLANTED POLY LINER AND IMPLANTED NEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD WORN POLY IN 17 YEAR OLD KNEE. SURGEON EXPLANTED POLY LINER AND IMPLANTED NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66096 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1