BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN COMPREHENSIVE REVERSE TRAY

    MDR report key: 23017346 · Received September 10, 2025

    Report

    Report Number
    0001825034-2025-02866
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    June 3, 2025
    Report Date
    April 20, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    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 STEM(UNKNOWN). - UNKNOWN COMPREHENSIVE REVERSE BEARING(UNKNOWN). - UNKNOWN COMPREHENSIVE REVERSE BASEPLATE(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 AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H6, H10, H11 D4: THE PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE DEVICE'S PRODUCT NUMBER IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. THE REPORTED EVENT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION 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

    A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF SHOULDER AND ELBOW SURGERY 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. 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 3 PATIENTS EXPERIENCED A DEEP INFECTION REQUIRING REVISION. NO FURTHER DISCUSSION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    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
    80591 UNKNOWN COMPREHENSIVE REVERSE TRAY SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.