BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE 10 DEG INSERT

    MDR report key: 3094858 · Received May 6, 2013

    Report

    Report Number
    0002249697-2013-01566
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K974685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A C-TAPER COCR LFIT HEAD 32MM/+5, CAT # 06-3205, LOT # MJE274 WAS ALSO REPORTED. IT CANNOT BE DETERMINED IF EITHER OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING AN OMNIFIT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS DUE TO HOSPITAL POLICY. INSUFFICIENT MEDICAL RECORDS INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. ALL DEVICES IN THE REPORTED LOT AND STERILE LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED, FURTHER INFORMATION IS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION ISSUE. REMOVED 2041-2858, 06-2806, REIMPLANTED: 2041C-3258 LOT#33113501, 06-3205 LOT#MJE274.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION ISSUE. REMOVED 2041-2858, 06-2806 REIMPLANTED: 2041C-3258 LOT#33113501 06-3205 LOT#MJE274.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196110 CROSSFIRE 10 DEG INSERT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 33113501

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R