BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TAPERLOC FEMORAL STEM

    MDR report key: 6414258 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01672
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    March 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MEH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED IN THE ARTICLE: DATE OF EVENT - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, INITIAL REPORTER - THIS ARTICLE WAS WRITTEN BY YOUNG-KYUN LEE, YONG-CHAN HA, WOO-LAM JO, TAE-YOUNG KIM, WOON-HWA JUNG, KYUNG-HOI KOO, MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, EIGHT HIP HAD DEVELOPED GRADE I HETEROTOPIC OSSIFICATION AND TWO HIPS HAD DEVELOPED GRADE II HETEROTOPIC OSSIFICATION AT FOLLOW-UP. THE MINIMUM FOLLOW-UP PERIOD WAS 24 MONTHS. ALL OF THE ACETABULAR CUPS AND FEMORAL STEMS HAD RADIOGRAPHIC EVIDENCE OF BONE INGROWTH AT THE TIME OF LAST FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196230 UNKNOWN TAPERLOC FEMORAL STEM HIP PROSTHESIS MEH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other