BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2933643 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00415
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    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 UNKNOWN REJUVENATE MODULAR FEMORAL STEM. 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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPDATED IMPLANT DATE BASED ON ADDITIONAL INFORMATION. THE PATIENT IS (B)(6). 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

    THE PATIENT IS EXPERIENCING GROIN PAIN. IT IS NOTED THAT THE SYMPTOMS ARE MILD. THE SUBJECT IS AN (B)(6) HIGH RISK PATIENT. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 23 MONTHS SINCE INDEX SURGERY: COBALT - 27; CHROMIUM - 3.1. FUTHER FOLLOW UP IS PLANNED FOR THIS PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THE IMPLANTS ARE REGARDING THE PATIENT'S LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38646 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other