BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X27X46 HUM HEAD

    MDR report key: 15670079 · Received October 25, 2022

    Report

    Report Number
    0001825034-2022-02404
    Event Type
    Injury
    Date Received
    October 25, 2022
    Report Date
    November 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304460751
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WAS INITIAL REPORTED ON MFR:0001822565-2022-02451. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02403, 0001825034-2022-02405, 0001825034-2022-02406. CONCOMITANT MEDICAL PRODUCTS: ITEM#: 113952, SM HYBRID GLENOID BASE 4MM; LOT#: 539300, ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 960770, ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 057540, ITEM#: 113653, COMP PRIMARY STEM 13MM STD; LOT#: 987670. 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

    CMP-(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: 0001825034-2022-02403-1 0001825034-2022-02405-1 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. IT REMAINS THAT 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 A RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO BONE EROSION AND INSTABILITY ON AN UNKNOWN DATE. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    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
    2803319 VERSA-DIAL 46X27X46 HUM HEAD PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 113048 572420 00880304460751

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R