BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2931188 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00315
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN REJUVENATE MODULAR FEMORAL STEM - RIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. SIMILAR EVENTS HAVE OCCURRED FOR THE REJUVENATE MODULAR PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN DIAGNOSED WITH ALTR FOLLOWING IMPLANTATION OF A REJUVENATE MODULAR FEMORAL STEM IN HIS RIGHT HIP. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 36 MONTHS SINCE INDEX SURGERY: COBALT - 6.3; CHROMIUM - 1.7. INFECTION WAS ALSO DIAGNOSED; THE ORGANISM IDENTIFIED WAS (B)(6). THE PATIENT IS REPORTED TO BE ASYMPTOMATIC NOW. THE PATIENT IS RECEIVING CHRONIC SUPPRESSION FOR THEIR INFECTION. IT IS NOTED THAT THE NECK WAS EXCHANGED AT A PREVIOUS REVISION TO TREAT A LOOSE CUP. CORROSION WAS REPORTED TO BE OBSERVED, BUT IT IS NOT CLEAR WHERE IT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN DIAGNOSED WITH ALTR FOLLOWING IMPLANTATION OF A REJUVENATE MODULAR FEMORAL STEM IN HIS RIGHT HIP. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 36 MONTHS SINCE INDEX SURGERY: COBALT - 6.3; CHROMIUM - 1.7. INFECTION WAS ALSO DIAGNOSED; THE ORGANISM IDENTIFIED WAS S. LUGEDENSIS. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC NOW. THE PATIENT IS RECEIVING CHRONIC SUPPRESSION FOR THEIR INFECTION. IT IS NOTED THAT THE NECK WAS EXCHANGED AT A PREVIOUS REVISION TO TREAT A LOOSE CUP. CORROSION WAS REPORTED TO BE OBSERVED, BUT IT IS NOT CLEAR WHERE IT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37652 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other