BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2931205 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00318
    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

    AN EVENT REGARDING PAIN INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. A SEARCH OF THE (B)(4) COMPLAINT DATABASES COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. 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 PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS NOTED TO BE SYMPTOMATIC. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 33 MONTHS SINCE IMPLANTATION: COBALT - 16; CHROMIUM - 3. FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT. THIS EVENT CONCERNS THE PATIENT'S LEFT HIP. THE PATIENT HAS REJUVENATE MODULAR FEMORAL STEMS IMPLANTED IN HIS LEFT AND RIGHT HIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS NOTED TO BE SYMPTOMATIC. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 33 MONTHS SINCE IMPLANTATION: COBALT - 16; CHROMIUM - 3. FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT. THIS EVENT CONCERNS THE PATIENT'S LEFT HIP. THE PATIENT HAS REJUVENATE MODULAR FEMORAL STEMS IMPLANTED IN HIS LEFT AND RIGHT HIPS. IT WAS REPORTED THAT THE PATIENT HAS PAIN IN THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36791 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other