BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 17861408 · Received October 3, 2023

    Report

    Report Number
    0001825034-2023-02280
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    May 25, 2018
    Report Date
    October 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304217249
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02277-1. 0001825034-2023-02278-1. 0001825034-2023-02279-1. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02277, 0001825034-2023-02278, 0001825034-2023-02279, 0001825034-2023-02293. D10: MEDICAL PRODUCTS: ITEM#: 113954, MD HYBRID GLENOID BASE 4MM; LOT#: 429730. ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 966000. ITEM#: 113042, VERSA-DIAL 46X18X53 HUM HEAD; LOT#: 599250 ITEM#: 113633, COMP PRIMARY STEM 13MM MINI; LOT#: 394660 H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) AND A HALF YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) YEARS AGO FOR AN UNKNOWN REASON. THE PATIENT WAS REVISED FROM AND ANATOMIC SHOULDER TO A REVERSE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761830 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 898660 00880304217249

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.