BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8302899 · Received February 4, 2019

    Report

    Report Number
    1818910-2019-83174
    Event Type
    Injury
    Date Received
    February 4, 2019
    Report Date
    January 24, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    PRODUCT COMPLAINT #: (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

    LITERATURE ARTICLE ENTITLED: "ANALYSIS OF BEARING WEAR, WHOLE BLOOD AND SYNOVIAL FLUID METAL ION CONCENTRATIONS AND HISTOPATHOLOGICAL FINDINGS IN PATIENTS WITH FAILED ASR HIP RESURFACINGS", LARI LEHTOVIRTA, ET. AL, PUBLISHED IN LEHTOVIRTA ET AL. BMC MUSCULOSKELETAL DISORDERS (2017) 18: 523, DOI 10.1186/S12891-017-1894-5, REVIEWED BY CLINICIAN FOR MDR REPORTABILITY. THE STUDY REVIEWED 85 ASR RESURFACING HIPS, DETERMINING THAT THERE WAS DEMONSTRATED METAL BEARING WEAR OF BOTH COMPONENTS. BEARING WEAR VOLUME CORRELATED WITH BLOOD METAL ION LEVELS AND THE DEGREE OF NECROSIS AND MACROPHAGE INFILTRATION IN PERIPROSTHETIC TISSUES SUGGESTING A DOSE-RESPONSE RELATIONSHIP. PATIENTS REVISED DID NOT HAVE INFECTIONS, NOR WERE THERE REPORTS OF IMPLANT LOOSENING OR PERIPROSTHETIC FRACTURES. PATIENTS DEMONSTRATED ADVERSE REACTION TO METAL DEBRIS (ARMD), NECROSIS, SYNOVITIS, INFLAMMATION, AND IMPLANT BEARING WEAR: METAL. THIS REPORT ADDRESSES 85 INSTANCES OF THE UNKNOWN HIP FEMORAL HEAD PRODUCT, THE ASR RESURFACING FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96520 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention