BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE 10 DEG INSERT

    MDR report key: 3940756 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02761
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    October 24, 2002
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K974685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING PATIENT PAIN INVOLVING A CROSSFIRE INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: CLINICIAN REVIEW OF THE PROVIDED RECORDS CONCLUDED "THERE IS NO DOCUMENTATION THAT THE VAGUE COMPLAINTS NOTED IN THE EVENT DESCRIPTION ARE RELATED TO THE RIGHT TOTAL HIP ARTHROPLASTY OR ITS PROSTHETIC COMPONENTS." CONCLUSIONS: THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. A REVIEW OF THE PROVIDED RECORDS BY A CLINICAL CONSULTANT INDICATED THERE IS NO EVIDENCE THE EVENT IS DEVICE RELATED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 2051-3050, LOT # 79677201, DESCRIPTION: SECUR-FIT HA PSL SCREWLESS CUP 50MM; CAT # 6054-0711A, LOT # 78197904, DESCRIPTION: PRIMARY SECUR-FIT PLUS #7/11; CAT # S-1400-HH82, LOT # 86015002, DESCRIPTION: C-TAPER LFIT INTER HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY 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. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD PAIN, HARD TO LIFT LEGS TO GET IN AND OUT OF BED, CAR AND SHOWER. PATIENT ALSO HAS DISCOMFORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD PAIN, HARD TO LIFT LEGS TO GET IN AND OUT OF BED, CAR AND SHOWER. PATIENT ALSO HAS DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418291 CROSSFIRE 10 DEG INSERT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other