BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE® VERSA-DIAL® RSS GLENOSPHERE

    MDR report key: 20515482 · Received October 23, 2024

    Report

    Report Number
    0001822565-2024-03336
    Event Type
    Injury
    Date Received
    October 23, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00887868231278
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 110031407 (64644661); 110031423 (64673385). ASSOCIATED PRODUCT INFORMATION: 010000589 (66118770); 113625 (340260). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. THE REPORTED EVENT IS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO DUE TO INSTABILITY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION TO INCREASE CONSTRAINT ON AN UNKNOWN DATE. A CUSTOM IMPLANT REQUEST WAS SUBMITTED TO A COMPETITOR TO REPLACE ALL CURRENT IMPLANTS EXCEPT THE STEM AND GLENOID BASEPLATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294615 COMPREHENSIVE® VERSA-DIAL® RSS GLENOSPHERE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 64416244 00887868231278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other H11