BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 9342334 · Received November 19, 2019

    Report

    Report Number
    1818910-2019-115034
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    January 1, 2016
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    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 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. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. 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). (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, "HISTOPATHOLOGICAL CHARACTERIZATION OF CORROSION PRODUCT ASSOCIATED ADVERSE LOCAL TISSUE REACTION IN HIP IMPLANTS: A STUDY OF 285 CASES" WRITTEN BY BENJAMIN F. RICCIARDI, ALLINA A. NOCON, SETH A. JERABEK, GABRIELLE WILNER, ELIANNA KAPLOWITZ, STEVEN R. GOLDRING, P. EDWARD PURDUE AND GIORGIO PERINO PUBLISHED BY BMC CLINICAL PATHOLOGY RICCIARDI ET AL. BMC CLINICAL PATHOLOGY (2016) 16:3 DOI 10.1186/S12907-016-0025-9 WAS REVIEWED. THE ARTICLE'S PURPOSE: "THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE HISTOLOGICAL PATTERNS OBSERVED IN THE PERIPROSTHETIC TISSUE OF FAILED THA IN THREE DIFFERENT IMPLANT CLASSES DUE TO ALTR AND THEIR ASSOCIATION WITH CLINICAL FEATURES OF IMPLANT FAILURE." DEPUY PRODUCTS UTILIZED: ASR RESURFACING, ASR XL, PINNACLE ULTRAMET, MOM BEARING SROM - ALL RETRIEVED AS FAILURES DUE TO ALTR - ALL BEARING SURFACES MOM ADVERSE EVENTS: SOFT TISSUE NECROSIS, METALLIC AND BLACK PARTICLES (DEBRIS CONTRIBUTED TO WEAR AND CORROSION), DEVICE CORROSION, OSTEOLYSIS (CONTRIBUTED TO FOREIGN BODY DEBRIS), HYPERSENSITIVITY (NOTED BY INCREASED MACROPHAGES, LYMPHOCYTES, EOSINOPHILS), ELEVATED BLOOD ION LEVELS RANGING 0-169 CO AND 0-64 CR. AS THE ARTICLE DOES NOT SPECIFY WHICH PRODUCT PLATFORMS ARE ASSOCIATED WITH SPECIFIC ADVERSE EVENTS, PLATFORMS ARE GROUPED AND CAPTURED AS 1 IMPACTED PRODUCT FOR EACH PRODUCT TYPE. THE ARTICLE DOES NOT PROVIDED ADEQUATE INFORMATION TO DETERMINE ACCURATE QUANTITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138869 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT JDI DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention