BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3094854 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01565
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FAILURE INVOLVING AN UNKNOWN GMR'S FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: 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. ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 6495-6-040- GMR'S EXTENSION PIECE 40MM- LOT CODE: LBBCO; CAT. NO.: 6495-6-050- GMR EXTENSION PIECE 50MM- LOT CODE: LAZBZ. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN UNKNOWN GMRS KNEE FOUR YEARS AGO, AND THE IMPLANT FAILED. PATIENT REPORTS THAT THE IMPLANT WAS REPLACED ON (B)(6) 2013. PATIENT IS INQUIRING ON "EACH AND EVERY 'INGREDIENT'" OF THE IMPLANT TO ENSURE THAT HIS BODY IS NOT REACTING TO THE PROSTHESIS. PATIENT HAS HAD A ZIMMER AND A BIOMET KNEE FOR 18 AND 21 YEARS, RESPECTIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS AN UNKNOWN GMR'S KNEE FOUR YEARS AGO, AND THE IMPLANT FAILED. PATIENT REPORTS THAT THE IMPLANT WAS REPLACED ON (B)(6) 2013. PATIENT IS INQUIRING ON "EACH AND EVERY 'INGREDIENT'" OF THE IMPLANT TO ENSURE THAT HIS BODY IS NOT REACTING TO THE PROSTHESIS. PATIENT HAS HAD A ZIMMER AND A BIOMET KNEE FOR 18 AND 21 YEARS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196877 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention