BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8965201 · Received September 5, 2019

    Report

    Report Number
    1818910-2019-103184
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    January 26, 2013
    Report Date
    August 16, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    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 · 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 NUMBER WAS NOT PROVIDED. 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. 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 "MRI PREDICTS ALVAL AND TISSUE DAMAGE IN METAL-ON-METAL HIP ARTHROPLASTY" BY DANYAL H. NAWABI, STEPHANIE GOLD, STEVEN LYMAN, KARA FIELDS, DOUGLAS E. PADGETT, AND HOLLIS G. POTTER PUBLISHED BY CLINICAL ORTHOPAEDICS AND RELATED RESEARCH DOI: 10.1007/S11999-013-2788-Y ON 26 JANUARY 2013 WAS REVIEWED FOR REPORTABILITY. PURPOSE: "WITH THE EMPHASIS ON EARLY REVISION SURGERY IN CASES OF ALTR, THE USE OF MRI IN IDENTIFYING A FAILING MOM HIP IMPLANT WARRANTS INVESTIGATION. MARS MRI IS RECOGNIZED AS A USEFUL MODALITY IN THE ASSESSMENT OF ALTR AROUND MOM HIP IMPLANTS, SHOWING CHARACTERISTICS SUCH AS SIZE, SHAPE, AND CONTENTS OF LESIONS [10, 11, 27]. NEWER PROTOTYPE PULSE SEQUENCES ARE AVAILABLE THAT IMPROVE OBSERVATION OF SOFT TISSUE AROUND MOM HIP IMPLANTS [12]. HOWEVER, IT IS UNCLEAR WHETHER THESE MRI CHARACTERISTICS CORRESPOND TO ALTR THAT MAY RESULT IN SUBSTANTIAL INTRAOPERATIVE TISSUE DAMAGE. WE SOUGHT TO USE THIS TECHNOLOGY TO STUDY THE POTENTIAL OF MODIFIED MRI TO DETECT A SPECIFIC SUBSET OF ALTR AND INTRAOPERATIVE TISSUE DAMAGE AS EARLY AS POSSIBLE....WE THEREFORE (1) IDENTIFIED WHICH MRI CHARACTERISTICS CORRELATED WITH A HISTOLOGICALLY PROVEN ALTR (USING THE ALVAL SCORE) AND INTRAOPERATIVE TISSUE DAMAGE AND (2) DEVELOPED A PREDICTIVE MODEL USING MODIFIED MRI TO DETECT ALVAL AND QUANTIFY INTRAOPERATIVE TISSUE DAMAGE. OUR AIMS WERE TO IDENTIFY WHICH MRI CHARACTERISTICS CORRELATED WITH THE ALVAL SCORE AND INTRAOPERATIVE TISSUE DAMAGE AND TO DEVELOP A PREDICTIVE MODEL USING MODIFIED MRI TO DETECT ALVAL AS CONFIRMED BY HISTOLOGY AND TO QUANTIFY INTRAOPERATIVE TISSUE DAMAGE." THE ARTICLE IDENTIFIES 68 PATIENTS (70 HIPS) WHO UNDERGONE PREOPERATIVE MIRI FOLLOWED BY REVISION SURGERY. THERE WERE 31 MALES AND 37 FEMALES WITH MEDIAN AGE OF 52 AND 57 YEARS AND THE MEDIAN TIME TO REVISION WAS 36 MONTHS. REASONS FOR REVISION ASEPTIC ACETABULAR LOOSENING (N = 8), ASEPTIC FEMORAL LOOSENING (N = 3), COMPONENT MALALIGNMENT (N = 4 AND DETAILS NOT CLARIFIED), INFECTION (N = 1), AND UNEXPLAINED PAIN (N = 54). DEPUY ASR IMPLANTS WERE USED FOR 24 HIPS. LOOSENING WAS CONFIRMED INTRAOPERATIVELY. INTRAOPERATIVE TISSUE DAMAGE WAS GRADED AND RESULTED IN 32 HIPS OF THE 70 WITH MODERATE-SEVERE ALVAL; IMPACTED PRODUCTS: DEPUY ASR. ADVERSE EVENTS: REVISION, PAIN, OSTEOLYSIS, NODES, SYNOVITIS, ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757523 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention