BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3844177 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02007
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. INITIAL REPORTER ADVISED THAT SHE HAS NO CONTACT WITH THE PATIENT THEREFORE FURTHER INFORMATION IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    MY WIFE WAS AT A DINNER PARTY. WHEN ONE OF THE OTHER WOMEN AT THE PARTY (A NURSE PRACTITIONER) FOUND OUT I WAS A STRYKER EMPLOYEE, SHE INFORMED MY WIFE THAT SHE HAD A PARTIAL HIP REPLACEMENT 5 YEARS AGO AND THEY TOLD HER IT WOULD LAST 20 YEARS. SINCE THEN SHE HAS HAD BLOOD WORK DONE THAT REVEALED METAL IONS AND SHE KNOWS IT NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322021 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other