BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMP LK SCR 3.5HEX 4.75X25 ST

    MDR report key: 22530363 · Received July 17, 2025

    Report

    Report Number
    0001825034-2025-02158
    Event Type
    Death
    Date Received
    July 17, 2025
    Date of Event
    June 17, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677159
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - THE EVENT OCCURRED IN AUSTRALIA. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 115310(J7836529), 110032410(67185082), 115395(66792976), 180553(67271033), 180550(67338919), 180550(67338919), 113613(66840669). ASSOCIATED PRODUCT INFORMATION: 110031424(67233121), 110031399(67351423). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO HOSPITAL POLICY. 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; D9; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED EVENT IS NOT CONFIRMED. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENT'S PRE-EXISTING HEALTH CONDITIONS AND PERIOPERATIVE MANAGEMENT. IN THIS CASE THE PATIENT EXPIRED AFTER A SUCCESSFUL SURGERY IN THE POSTOPERATIVE AREA. CAUSE OF DEATH HAS NOT BEEN PROVIDED AND NO ADDITIONAL INFORMATION CONCERNING PATIENT PREOPERATIVE HEALTH HISTORY HAS BEEN PROVIDED. ANY SURGICAL PROCEDURE UNDER ANESTHESIA PLACES THE PATIENT AT RISK FOR BLEEDING, DVT/PE, CARDIAC STRESS, STROKE, MALIGNANT HYPERTHERMIA AND BLOOD PRESSURE IRREGULARITIES ALL OF WHICH COULD CONTRIBUTE TO A PATIENT HAVING SEVERE COMPLICATIONS AND EVEN DEATH. AS THIS IS NOT RELATED TO OUR PRODUCTS OR INSTRUMENTATION WE WOULD NOT CONSIDER THIS DEVICE RELATED, BUT RELATED TO THE PROCEDURE. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. 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 THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    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
    839746 COMP LK SCR 3.5HEX 4.75X25 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. 66890490 00880304677159

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death| H SEE H11