BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2936161 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00495
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    July 1, 2010
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT DATABASES SHOW THERE HAVE NOT BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND 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.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS UNKNOWN REJUVENATE MODULAR 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT IS HAVING PAIN. PATIENT HAD AN MRI DONE AND HAS A HIGH LEVEL OF COBALT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT IS HAVING PAIN. PATIENT HAD AN MRI DONE AND HAS A HIGH LEVEL OF COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40225 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MHT0TL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other