BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10

    MDR report key: 2931181 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00320
    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
    PMA / PMN Number
    K092561
    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 AN UNKNOWN REJUVENATE MODULAR FEMORAL STEM - RIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALTR 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 SUPER AND CHS COMPLAINT DATABASES SHOW THERE HAVE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS NOTED TO BE SYMPTOMATIC. THE FOLLOWING MEASUREMENTS WERE RECORDED AT 19 MONTHS SINCE IMPLANTATION: COBALT - 16; CHROMIUM - 3. THIS EVENT CONCERNS THE PATIENT'S RIGHT 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 19 MONTHS SINCE IMPLANTATION: COBALT - 16; CHROMIUM - 3. THIS EVENT CONCERNS THE PATIENT'S RIGHT HIP. THE PATIENT HAS REJUVENATE MODULAR FEMORAL STEMS IMPLANTED IN HIS LEFT AND RIGHT HIPS. IT WAS REPORTED THAT PATIENT HAS FLUID BUILDUP ON RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36677 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH LOT: MJT49W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R