BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 8732661 · Received June 25, 2019

    Report

    Report Number
    1818910-2019-96800
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    June 6, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> 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 CODE(S) 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. CORRECTIVE ACTION WAS NOT INDICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED "THE ELITE PLUS TOTAL HIP ARTHROPLASTY-THE NEED FOR RADIOLOGICAL SURVEILLANCE¿ BY N.P. WALTON ET. AL, PUBLISHED IN THE JOURNAL OF BONE AND JOINT SURGERY(BR) 2005; 87-B: 458-62 WAS REVIEWED FOR MDR REPORTABILITY. THE STUDY ANALYZED THE MEDIUM-TERM OUTCOME OF THE ELITE PLUS TOTAL HIP ARTHROPLASTY SYSTEM. 217 PATIENTS WITH 234 THAS UNDERWENT AN ELITE PLUS THA WITH A 28 MM ORTRON 90 HEAD DURING 1995 AND WERE CLINICALLY FOLLOWED. COMPETITOR CEMENT WAS USED. 1 OF THE THAS IMMEDIATELY POST-OP WAS GRADED C OR D BASED ON CRITERIA OF BARRACK, MULROY, AND HARRIS INDICATING LOOSENING THOUGH THIS CANNOT BE CONFIRMED UNTIL REVISION. 19 ACETABULAR PROGRESSIVE RADIOLUCENT LINES WERE NOTED ON XRAY AT FOLLOWUP THOUGH ONCE AGAIN, LOOSENING CANNOT BE CONFIRMED UNTIL REVISION. OF THE 217 PATIENTS (234 THAS) THE FOLLOWING EVENTS WERE IDENTIFIED: 9 PATIENTS WERE REVISED FOR UNKNOWN REASON PRIOR TO FOLLOWUP; 52 THAS SHOWED EITHER DEFINITE EVIDENCE OF LOOSENING OF THE COMPONENT OR HAD BEEN REVISED FOR LOOSENING OF THE COMPONENT WITHIN 6 YEARS; 48 STEMS WERE NOTED TO BE MISPOSITIONED IN VARUS/VALGUS. THE ARTICLE INDICATED THAT 39 PATIENTS DIED PRIOR TO FOLLOW-UP BUT NO CAUSE NOTED NOR INDICATION IT WAS PRODUCT RELATED. THE PREVIOUS ARTICLE REVIEWED WAS PUBLISHED IN 2006. AFTER REVIEW OF UPDATED STUDY PUBLISHED IN 2009, THE FOLLOWING ADDITIONAL ADVERSE EVENTS WERE NOTED: 1 REVISION DUE TO EARLY DEEP INFECTION. PAIN ATTRIBUTED TO MULTIPLE CASES OF LOOSENING. 3 PATIENTS WERE REVISED FOR LOOSENING OF THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523519 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention