BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID GLENOID BASE 4MM

    MDR report key: 7379299 · Received March 28, 2018

    Report

    Report Number
    0001825034-2017-06831
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    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, VERSA-DIAL 42X18X46 HUM HEAD PART # 113032 LOT # 002210, PT HYBRID GLEN POST REGENEREX PART # PT-113950 LOT # 090870. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06830. 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 RELEVANT TO THE REPORTED EVENT 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
    221049 SM HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 198900

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other