BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BI-METRIC STEM

    MDR report key: 4409571 · Received January 12, 2015

    Report

    Report Number
    0001825034-2015-00114
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    December 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "CHANGES IN FEMORAL STEM GEOMETRY REDUCE INTRAOPERATIVE FEMORAL FRACTURE RATES IN TOTAL HIP REPLACEMENT" WHICH INVESTIGATED THE INFLUENCE OF CHANGES IN STEM DESIGN ON INTRAOPERATIVE FRACTURE RATES. THE STUDY WAS CONDUCTED OVER A PERIOD OF TWENTY-EIGHT (28) YEARS (JULY 1986 TO JANUARY 2014) IN WHICH 3140 TOTAL HIP ARTHROPLASTIES (THAS) WERE PERFORMED WITH UNCEMENTED BI-METRIC AND ECHO BI-METRIC STEMS (BIOMET, INC.). OF THESE, 1497 BI-METRIC STEMS WERE IMPLANTED (1280 PATIENTS). BEGINNING IN 2005, 1277 ECHO BI-METRIC STEMS WITH FULL PROXIMAL PROFILE (FPP) WERE IMPLANTED (1104 PATIENTS) AND 366 ECHO BI-METRIC STEMS WITH REDUCED PROXIMAL PROFILE (RPP) WERE IMPLANTED (317 PATIENTS). THE AVERAGE AGE AT SURGERY WAS 62.4, 64.8 AND 63.2 YEARS WITH BI-METRIC, ECHO BI-METRIC FPP AND ECHO BI-METRIC RPP, RESPECTIVELY. IN ALL COHORTS, OSTEOARTHRITIS WAS THE MOST COMMON PREOPERATIVE DIAGNOSIS, FOLLOWED BY AVASCULAR NECROSIS AND RHEUMATOID ARTHRITIS. THE JOURNAL ARTICLE REPORTS THAT THERE WERE EIGHTY-TWO (82) INTRAOPERATIVE FRACTURES IN THE BI-METRIC GROUP, EIGHTEEN (18) FRACTURES IN THE ECHO BI-METRIC FPP GROUP, AND FIVE (5) FRACTURES IN THE ECHO BI-METRIC RPP GROUP. BI-METRIC STEMS HAD FOUR TIMES THE ODDS OF INTRAOPERATIVE FRACTURE COMPARED TO THE ECHO FPP STEMS, AND SIX TIMES THE ODDS OF INTRAOPERATIVE FRACTURE COMPARED TO THE ECHO RPP STEMS. THERE WAS NO STATISTICAL DIFFERENCE BETWEEN ECHO FPP AND RPP STEMS. THERE WAS NO STEM REVISION SO FAR IN ALL THE BI-METRIC, ECHO FPP AND ECHO RPP STEMS. STEM SURVIVORSHIP WITH ASEPTIC LOOSENING AS AN ENDPOINT WAS ONE HUNDRED PERCENT (100%) IN ALL COHORTS AT THE FINAL FOLLOW-UP. THE AUTHORS OF THE STUDY CONCLUDE THAT CHANGES IN FEMORAL STEM GEOMETRY IN UNCEMENTED THA REDUCE INTRAOPERATIVE FRACTURE RATES WHILE PRESERVING FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27542 UNKNOWN BI-METRIC STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention