BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3140707 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01836
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN BASEPLATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE OTHER DEVICE LISTED IN THE REPORT IS AN UNKNOWN INSERT. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING AN UNKNOWN BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATIONS COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. NO PATIENT MEDICAL RECORDS WERE RETURNED OR MADE AVAILABLE FOR REVIEW. A DEVICE HISTORY REVIEW COULD NOT PERFORMED AS THE LOT NUMBER OF THE REPORTED DEVICE WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED FOR IDENTIFICATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE REPORTED EVENT COULD NOT BE CONFIRMED. NO DEVICES WERE RETURNED AND NO MEDICAL RECORDS WERE PROVIDED FOR EVALUATION, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED AN OSTEONIC SERIES 7000- RIGHT KNEE- DUE TO PATIENT EXPERIENCING PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED AN OSTEONIC SERIES 7000- RIGHT KNEE- DUE TO PATIENT EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242144 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention