BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X27X50 HUM HEAD

    MDR report key: 17942163 · Received October 16, 2023

    Report

    Report Number
    0001825034-2023-02388
    Event Type
    Injury
    Date Received
    October 16, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304460775
    PMA / PMN Number
    K193038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-02133-1, 0001825034-2023-02389. D10: MEDICAL PRODUCTS: ITEM#: 113634, COMP PRIMARY STEM 14MM MINI; LOT#: 64877613. ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: J7422270. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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: 0001825034-2023-02133-2; 0001825034-2023-02389-1. H6: COMPONENT CODES: MECHANICAL (G04)- HEAD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY TWO YEARS AGO. THE PATIENT UNDERWENT A TWO-STAGE REVISION SURGERY, THE FIRST STAGE A YEAR AND A HALF AFTER THE INITIAL SURGERY AND THE SECOND APPROXIMATELY FOUR MONTHS AGO DUE TO THE SCREWS FRACTURING. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR AN ADDITIONAL REVISION SURGERY DUE TO THE PATIENT BEING UNHAPPY WITH THE RESULTS OF HER PREVIOUS REVISION SURGERIES AND DISCOMFORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115894 VERSA-DIAL 50X27X50 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 450570 00880304460775

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE.