BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERS/REVERS SCR SYST 4.5-36

    MDR report key: 22942640 · Received September 2, 2025

    Report

    Report Number
    0009613350-2025-00684
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 28, 2024
    Report Date
    January 28, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    PHX
    UDI-DI
    00889024483040
    PMA / PMN Number
    K052906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS FOR BOTH PRODUCTS. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. IT IS NOTED IN THE DILIGENCE THAT THE SURGEON SUSPECTS A PATIENT FALL WHICH CAUSED THE GLENOID FRACTURE, THE PATIENT THOUGH DID NOT RECALL EXPERIENCING A FALL THEREFORE 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: NVERS/REVERS SCR, #ITEM 0104223030, #LOT 3151019 15MM POST LENGTH BASE PLATE, #ITEM 00434901500, #LOT 65901222 COMP VRS BONE AND IMP MDL, #ITEM 110031178, #LOT 66860970 2.5MM ÿ PIN, #ITEM 47430902501, #LOT 65852912 MODULAR HUMERAL HEAD , #ITEM 00430004627, #LOT 63257297 12MM ÿ 130MM LENGTH HUMERAL STEM, #ITEM 00434901213, #LOT 65990432 DUAL TAPER INSERT, #ITEM 00434903700, #LOT 65361565. GENEX 10CC KT W/BEAD MOLD TRAY, #ITEM 910-010Z, #LOT GB230102. THERAPY DATE: (B)(6) 2024. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION ONE YEAR LATER DUE TO A FRACTURED GLENOID BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260395 INVERS/REVERS SCR SYST 4.5-36 IMPLANT TRAUMA PHX ZIMMER GMBH 3147820 00889024483040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE