BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3540493 · Received December 27, 2013

    Report

    Report Number
    0002249697-2013-04208
    Event Type
    Injury
    Date Received
    December 27, 2013
    Date of Event
    June 19, 2013
    Report Date
    December 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN RESTORATION HA.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER. 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, WHEN THE PATIENT WAS (B)(6) (MALE), HE HAD A PRIMARY BHA BY USING UNKNOWN BHA SYSTEM. EIGHT YEARS LATER, HE HAD 1ST REVISION BHA DUE TO A STEM LOOSENING BY USING UNKNOWN BHA SYSTEM. THREE YEARS LATER, THE STEM STARTED LOOSENING. THE PATIENT HAD 2ND REVISION SURGERY TO REPLACE THE STEM BY USING A RESTORATION HA STEM. THE STEM STARTED SINKING IN EARLY POSTOPERATIVE PERIOD. FOUR YEARS LATER, THE STEM SANK TOTAL 37MM. THE PATIENT HAD 3RD REVISION SURGERY BY USING AN EXETER STEM (IBG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677037 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention