BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 9364908 · Received November 22, 2019

    Report

    Report Number
    1818910-2019-116835
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    January 1, 2000
    Report Date
    October 29, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    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). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

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

    Description of Event or Problem · 1

    "THE LITERATURE ARTICLE ENTITLED, ""FACTORS CONTRIBUTING TO RAPID WEAR AND OSTEOLYSIS IN HIPS WITH MODULAR ACETABULAR BEARINGS MADE OF HYLAMER"" WRITTEN BY DAVID L. SCOTT, MD, DVM, PHD, PAT A. CAMPBELL, PHD, CHRISTIAN D. MCCLUNG, MPHIL, AND THOMAS P. SCHMALZRIED, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY VOLUME 15 NO. 1 2000 WAS REVIEWED. THE ARTICLE'S PURPOSE IS TO ANALYZE RADIOGRAPHS, COMPONENTS AND PERIARTICULAR TISSUE RETRIEVED AT REVISION SURGERY TO IDENTIFY THE FACTORS ASSOCIATED WITH RAPID WEAR AND RETRO ACETABULAR OSTEOLYSIS WITH A MODULAR ACETABULAR LINER MADE OF HYLAMER. DATA IS COMPILED FROM 12 PATIENTS THAT ARE DESCRIBED IN TABLES AND NARRATIVE DESCRIPTIONS WITH ASSOCIATED ADVERSE EVENTS. EACH PATIENT HAD DEPUY PRODUCT IMPLANTS AND ARE INDIVIDUALLY CAPTURED IN LINKED COMPLAINTS. OSTEOLYSIS IS ATTRIBUTED TO POLY LINER WEAR. ALSO NOTED THAT ARTICLE REPORTS METAL PARTICLES (DEBRIS) WERE FOUND EMBEDDED IN THE LINER WHICH DENOTES HEAD WEAR. ALSO NOTED THAT THE ARTICLE PROVIDES LOT NUMBERS FOR THE POLY LINERS." THIS COMPLAINT CAPTURES CASE 12 A (B)(6) FEMALE WITH L HIP IMPLANTS OF S-ROM FEMORAL COMPONENT AND DURALOC 1200 ACETABULAR COMPONENT 56 MM, COCR HEAD 28 MM, 10 MM LINER THICKNESS FROM LOT #685000 INITIALLY IMPLANTED 11/13/92 AND REVISED 10/10/96 FOR POLY WEAR AND OSTEOLYSIS. FEMORAL FIXATION WAS LOOSE AND ACETABULUM FIXATION WAS STABLE. LYSIS FOUND IN DIFFUSE AREAS OF THE FEMUR AND ZONE II OF ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157703 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention