BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9452693 · Received December 11, 2019

    Report

    Report Number
    1818910-2019-122455
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    March 20, 2006
    Report Date
    November 18, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT #:(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "FATAL CEREBRAL EMBOLI IN THE ABSENCE OF A CARDIAC ARTERIAL-VENOUS SHUNT" WRITTEN BY JENNIFER TUCKER AMMON, MD, CYNA KHALILY, MD, AND D. KEVIN LESTER, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY VOL. 22 NO. 3 2007 ACCEPTED BY PUBLISHER 20 MARCH 2006 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO REPORT ON ONE CASE REPORT OF A (B)(6) YEAR OLD MENTALLY DELAYED FEMALE WHO UNDERWENT A CEMENTLESS BIPOLAR HEMIARTHROPLASTY FOR TREATMENT OF A DISPLACED SUBCAPITAL FEMORAL NECK FRACTURE. A DEPUY FEMORAL STEM AND FEMORAL HEAD WAS UTILIZED. INTRAOPERATIVELY SHE REMAINED HEMODYNAMICALLY STABLE AND WELL PERFUSED WITH OXYGEN LEVELS THROUGHOUT OPERATION. SIX HOURS POST OP THE PATIENT HAD NOT AWAKENED FROM SURGERY. MRI IMAGING REVEALED 22 FAT EMBOLI. SHE DID NOT REGAIN PREVIOUS CONSCIOUSNESS OR FUNCTION AND 10 MONTHS LATER SHE DIED BECAUSE OF SEVERE GENERALIZED DEBILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245774 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention