BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BASEPLATE

    MDR report key: 24482980 · Received March 2, 2026

    Report

    Report Number
    0001825034-2026-00471
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 2, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-1030956 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS IN THE D10 NARRATIVE BELOW. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 118000 (J7678281). ASSOCIATED PRODUCT INFORMATION: 115313 (J7607286). 110031405 (66675781). 110031418 (67286771). THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROGRESS. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 FOLLOWING A RIGHT REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT EXPERIENCED DISASSOCIATION OF THE GLENOSPHERE AND BASEPLATE ON MULTIPLE OCCASIONS. THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY SEVEN (7) WEEKS POST-IMPLANTATION DUE TO DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539570 UNKNOWN BASEPLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H