BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9213843 · Received October 21, 2019

    Report

    Report Number
    1818910-2019-110869
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    April 18, 2011
    Report Date
    September 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    "LITERATURE ARTICLE ENTITLED, ¿MEDIUM-TERM RESULT OF ELITE PLUS HIP ARTHROPLASTY: THE SECOND MODULAR EVOLUTION OF THE ORIGINAL CHARNLEY LOW-FRICTION ARTHROPLASTY¿ BY TAICHI IRIE, ET AL, PUBLISHED BY JOURNAL OF ORTHOPAEDIC SCIENCE (2012), VOL 17, PP. 699-704, DOI 10.1007/S00776-012-0296-7, WAS REVIEWED FOR MDR REPORTABILITY. THE AIM OF THIS STUDY WAS TO CLARIFY THE MEDIUM-TERM RESULTS AND THE FACTORS AFFECTING THE RESULTS OF ELITE PLUS THA IN PATIENTS IMPLANTED BETWEEN 1994 AND 2002. THE RESULTS OF 97 ELITE PLUS THAS IN 87 PATIENTS AT 5 YEARS OR MORE POSTOPERATIVELY WERE REVIEWED. IMPLANTED PRODUCTS: THE ELITE PLUS STEM WAS USED IN ALL HIPS, AND THREE DESIGNS OF SOCKET, HYLAMER OGEE IN 40 HIPS, WROBLEWSKI OFFSET BORE (CHARNLEY) IN 38, AND CHARNLEY OGEE IN 19, WERE IMPLANTED. ALL PATIENTS RECEIVED A 22-MM COCR FEMORAL HEAD. THE SURVIVAL RATES WITH LOOSENING AND REVISION AS ENDPOINTS WERE ANALYZED. EXTENSIVE SERIAL RADIOGRAPHS WERE TAKEN THROUGHOUT THIS STUDY. RESULTS: 25 REVISIONS DUE TO ACETABULAR ASEPTIC LOOSENING, MIGRATION, AND/OR POLYETHYLENE WEAR. 5 REVISIONS DUE TO ASEPTIC LOOSENING AND/OR MIGRATION OF THE STEM. 15 INSTANCES OF RADIOLOGICALLY IDENTIFIED POLYETHYLENE OGEE CUP WEAR WITH FEMORAL HEAD PENETRATION. ACETABULAR AND FEMORAL OSTEOLYSIS WAS IDENTIFIED IN MULTIPLE PATIENTS WITH VARYING DEGREES OF SEVERITY. THERE IS NO ADDITIONAL INFORMATION PROVIDED WITHIN THE TEXT OF THIS ARTICLE. THERE IS NO REPORTED PRODUCT PROBLEMS WITH THE IMPLANTED FEMORAL HEADS. THE AUTHORS PROVIDE INFORMATION FOR A SINGLE PATIENT IN FIGURE 2 ON PAGE 701. THIS PATIENT IS IDENTIFIED WITHIN THE GUIDANCE DOCUMENT AS 64 YO FEMALE. PLEASE LINK THIS ADDITIONAL PC TO (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008146 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention