BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3223689 · Received July 12, 2013

    Report

    Report Number
    0002249697-2013-02274
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN POLY INSERT. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION, HISTORY REVIEW OR COMPLAINT HISTORY WAS PERFORMED AS NO DEVICES WERE RECEIVED OR IDENTIFIED. NO PATIENT MEDICAL RECORDS WERE RETURNED OR MADE AVAILABLE FOR REVIEW. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. THE REPORTED EVENT REGARDING REVISION OF AN UNKNOWN KNEE INSERT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS KNEE PAIN, POLY EXCHANGE WENT FROM 14MM TO 16MM INSERT THICKNESS. PREVIOUS SURGERY (REVISION) DONE 2008 IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS KNEE PAIN, POLY EXCHANGE WENT FROM 14MM TO 16MM INSERT THICKNESS. PREVIOUS SURGERY (REVISION) DONE 2008 IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321357 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention