BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE TRAY

    MDR report key: 23022163 · Received September 10, 2025

    Report

    Report Number
    0001825034-2025-02878
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    June 3, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - THE EVENT OCCURRED IN ARGENTINA. 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): UNKNOWN COMPREHENSIVE REVERSE BEARING(UNKNOWN). UNKNOWN COMPREHENSIVE REVERSE BASEPLATE(UNKNOWN). UNKNOWN COMPREHENSIVE REVERSE TRAY(UNKNOWN). UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE(UNKNOWN). G2: LITERATURE: REVERSE SHOULDER ARTHROPLASTY WITH TUBEROSITY HEALING AFTER PROXIMAL HUMERAL FRACTURES AND ROTATOR CUFF ARTHROPATHY: SIMILAR FUNCTIONAL OUTCOMES AND COMPLICATIONS IN PATIENTS AFTER 10 YEARS FOLLOW-UP VACCARO, RAMIRO ET AL. JOURNAL OF SHOULDER AND ELBOW SURGERY, VOLUME 0, ISSUE 0 DOI10.1016/J.JSE.2025.04.030. THE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D1; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF SHOULDER AND ELBOW SURGERY (2025) THAT REPORTED A RETROSPECTIVE STUDY FROM ARGENTINA. THE PURPOSE OF THE STUDY WAS TO COMPARE THE FUNCTIONAL OUTCOMES, COMPLICATIONS, AND REVISION RATES OF REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) FOR THE TREATMENT OF PROXIMAL HUMERAL FRACTURES (PHFS) IN PATIENTS WHO ACHIEVED ANATOMICAL TUBEROSITY HEALING AND THOSE TREATED WITH RTSA FOR ROTATOR CUFF ARTHROPATHY (RCA) AFTER A MINIMUM FOLLOW-UP PERIOD OF 8 YEARS. THE STUDY REVIEWED 118 PATIENTS (42 MALE, 76 FEMALE) WHO UNDERWENT RTSA FOR PHFS AND RCA AT THE HOSPITAL ITALIANO DE BUENOS AIRES. PATIENTS WERE DIVIDED IN 3 GROUPS FOR THE ANALYSIS: GROUP 1 (39 SHOULDERS): RTSA FOR PHF IN WHICH ANATOMICAL TUBEROSITY HEALING WAS ACHIEVED; GROUP 2 (29 SHOULDERS): RTSA FOR PHF IN WHICH ANATOMICAL TUBEROSITY HEALING WAS NOT ACHIEVED (INCLUDING NONUNIONS AND MALUNIONS OF THE TUBEROSITIES); GROUP 3 (50 SHOULDERS): RTSA FOR RCA. THE STUDY REPORTED 1 PATIENT EXPERIENCED AN UNKNOWN NERVE INJURY. NO FURTHER DISCUSSION REGARDING TREATMENT OR INTERVENTION WAS NOTED; HOWEVER, NO REVISION WAS REQUIRED. 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
    2373029 UNKNOWN COMPREHENSIVE REVERSE TRAY SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11.