BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 6431030 · Received March 24, 2017

    Report

    Report Number
    0001825034-2017-01734
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    December 17, 2016
    Report Date
    May 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    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.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DATE LISTED: DATE JOURNAL ARTICLE WAS ACCEPTED. CONCOMITANT MEDICAL PRODUCTS - UNKNOWN BI-METRIC FEMORAL STEM, UNKNOWN ACETABULAR CUP, UNKNOWN ACETABULAR LINER, ALL CATALOG#'S: NI ALL LOT'S#: NI; THERAPY DATE: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS.

    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, TWO PATIENTS UNDERWENT REVISION OF CUP AND LINER AT 2 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE RECEIVED THAT TWO PATIENTS UNDER HIP REVISION PROCEDURES APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE FEMORAL HEADS AND ACETABULAR LINERS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215236 UNKNOWN HEAD PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R