BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE MODULAR HEAD - VARIABLE OFFSET

    MDR report key: 7379523 · Received March 28, 2018

    Report

    Report Number
    0001825034-2017-06830
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 22, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 9MM MINI PART # 113629 LOT # 125790. VERSA-DIAL/COMP TI STD TAPER PART # 118001 LOT # 698350. PT HYBRID GLEN POST REGENEREX PART # PT-113950 LOT # 090870. SM HYBRID GLENOID BASE 4MM PART # PT-113950 LOT # 090870. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06831. REPORTED EVENT WAS CONFIRMED THROUGH CLINICAL EVALUATION FORMS RECEIVED. RADIOGRAPH REVIEW CONFIRMED GLENOID RADIOLUCENCY, HOWEVER THIS WAS NOTED TO NOT BE DEVICE RELATED AND WAS NOTED TO HAVE RESOLVED BY 6 WEEKS POST-OPERATIVELY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, INSTABILITY WAS NOTED IN CLINICAL FOLLOW-UPS APPROXIMATELY THREE (3) MONTHS AND ONE (1) YEAR POST-OPERATIVELY. HOWEVER, PATIENT IS NOTED TO BE SATISFIED AND NO REVISION PROCEDURE HAS BEEN INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221458 COMPREHENSIVE MODULAR HEAD - VARIABLE OFFSET PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 002210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other