BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STEM

    MDR report key: 6432607 · Received March 24, 2017

    Report

    Report Number
    0001825034-2017-01867
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Report Date
    March 22, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF ANY FURTHER INFORMATION IS RECEIVED THAT ALTERS OUR CONCLUSION OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    JOURNAL ARTICLE , "PREPARATION OF THE FEMORAL BONE CAVITY FOR CEMENTLESS STEMS: BROACHING VS COMPACTION. A FIVE-YEAR RANDOMIZED RADIOSTEREOMETRIC ANALYSIS AND DUAL ENERGY X-RAY ABSORPTION STUDY" WAS RECEIVED INVOLVING CEMENTLESS HYDROXYAPATITE-COATED BI-METRIC STEMS (BIOMET, INC.), REPORTED THAT FOUR STEMS IN THE COMPACTION GROUP EXPERIENCED MIGRATIONS AT 1 YEAR POST-IMPLANTATION. TWO OF THE STEMS MIGRATED MEDIALLY AND 2 MIGRATED LATERALLY. AT 5 YEARS POST-IMPLANTATION, 3 OF THE 4 STEMS CONTINUED TO MIGRATE. IN SUMMARY, THE COMPACTION GROUP WAS FOUND TO HAVE A LARGER ABSOLUTE MEAN MIGRATION AT 1 AND 5 YEARS, AND LARGER VALGUS/VARUS ROTATIONS AT 1-YEAR FOLLOW-UP. FURTHERMORE, THE INDIVIDUAL MIGRATIONS REVEALED THAT STEMS WITH MEASURABLE MEDIO/LATERAL TRANSLATIONS OR VALGUS/VARUS ROTATIONS WERE ALL IN THE COMPACTION GROUP. NO INTERVENTION WAS REPORTED AND PATIENT OUTCOME IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215709 UNKNOWN STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1