BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2936168 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00489
    Event Type
    Injury
    Date Received
    January 30, 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 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.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE NECK. 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 PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN DIAGNOSED WITH ALTR. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 27 MONTHS SINCE INDEX SURGERY: COBALT - 4.7; CHROMIUM - 0.2. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC. INFECTION HAS NOT BEEN DIAGNOSED. NO FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT. ADDITIONAL NOTES: MEDICAL RISK TOO HIGH FOR SURGERY.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN DIAGNOSED WITH ALTR. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 27 MONTHS SINCE INDEX SURGERY: COBALT - 4.7; CHROMIUM - 0.2. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC. INFECTION HAS NOT BEEN DIAGNOSED. NO FURTHER FOLLOW UP IS PLANNED FOR THIS PATIENT. ADDITIONAL NOTES: MEDICAL RISK TOO HIGH FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41539 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other