BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2963527 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00685
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 5-13 INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TOOK OUT KNEE POLY TO IRRIGATE A POSSIBLE INFECTION WITHIN THE KNEE. AFTER IRRIGATION A NEW POLY WAS INSERTED

    Description of Event or Problem · 1

    TOOK OUT KNEE POLY TO IRRIGATE A POSSIBLE INFECTION WITHIN THE KNEE. AFTER IRRIGATION A NEW POLY WAS INSERTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66525 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR