BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP

    MDR report key: 3782118 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03438
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 26, 1992
    Report Date
    April 2, 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
    OH, 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN ; DATE IMPLANTED - 1987; PMA/510(K) NUMBER; MANUFACTURE DATE ¿ UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-00534 & 03438).

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY IN 1987. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 1992 DUE TO AN UNKNOWN REASON. PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2010 DUE TO LOOSENING OF THE FEMORAL STEM AND ACETABULAR CUP WITH ACETABULAR BONE LOSS. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT AND A BIOMET CALCAR, FEMORAL STEM AND MODULAR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260967 UNKNOWN HIP PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R