BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2933738 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00438
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    March 1, 2011
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN REJUVENATE STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN 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 PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN IN THE GROIN AREA. THE PATIENT IS ALSO REPORTING HIGH COBALT LEVELS IN THE BLOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN IN THE GROIN AREA. THE PATIENT IS ALSO REPORTING HIGH COBALT LEVELS IN THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39276 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other