BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X18X53 HUM HEAD

    MDR report key: 7448731 · Received April 20, 2018

    Report

    Report Number
    0001825034-2018-02904
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    April 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 118001, VERSA-DIAL/COMP TI STD TAPER, 582630, 113633, COMP PRIMARY STEM 13MM MINI, 421850, 113952, SM HYBRID GLENOID BASE 4MM, 116850, PT-113950, PT HYBRID GLEN POST REGENEREX, 242120, 110003484, ACCESS 3.2MM THD STEINMANN 9, 653240, 98B00901502, COMP SHRT ST/RGX GLD/RSDL HD, UNKNOWN, 98B00901702, COMP SHRT RSDL HD, UNKNOWN, 110003484, ACCESS 3.2MM THD STEINMANN 9, 653240. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02903, 0001825034 - 2018 - 02902.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6) 2017; (B)(6) 2016. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289644 VERSA-DIAL 46X18X53 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 301360

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R