BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2990620 · Received March 5, 2013

    Report

    Report Number
    0002249697-2013-00913
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 1, 2007
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE LIMITED INFORMATION WAS PROVIDED. THE RETURNED DEVICE, DEVICE INFORMATION, AND MEDICAL RECORDS ARE NEEDED TO FURTHER INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; A CLOSE FAMILY FRIEND HAD HIP SURGERY BACK IN (B)(6) 2007 AND SAID IT WAS A STRYKER HIP. SHE¿S BEEN IN A LOT OF PAIN AND IS THINKING ABOUT GETTING A REVISION SURGERY. SHE MENTIONED SOMETHING TO MY MOTHER ABOUT THE IMPLANT BEING TOO LONG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; A CLOSE FAMILY FRIEND HAD HIP SURGERY BACK IN (B)(6) OF 2007 AND SAID IT WAS A STRYKER HIP. SHE'S BEEN IN A LOT OF PAIN AND IS THINKING ABOUT GETTING A REVISION SURGERY. SHE MENTIONED SOMETHING TO MY MOTHER ABOUT THE IMPLANT BEING TOO LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94274 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other