BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3540988 · Received December 29, 2013

    Report

    Report Number
    0002249697-2013-04227
    Event Type
    Injury
    Date Received
    December 29, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN CR POLY INSERT 10MM. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 7125-0011, SERIES 7000 STANDARD M/S TIBIA, LOT CODE: T010601. CAT. NO.: 70-5113L, SCORPIO CR M/S FEMUR W/LFIT, LOT CODE: K00N554. CAT. NO.: UNK, UNKNOWN PATELLA, LOT CODE: UNK. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SURGEON DREW FLUID FROM PATIENT TO DETERMINE IF INFECTED. RESULT OF TEST DETERMINED INFECTION. PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2013 AND IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER USED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678862 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention