BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHO FX 9MM STD FEMORAL

    MDR report key: 23586408 · Received November 18, 2025

    Report

    Report Number
    0001825034-2025-03687
    Event Type
    Death
    Date Received
    November 18, 2025
    Date of Event
    June 13, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K063614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H6. D10: ZIMMER BIOMET PART # 110010242, LOT # UNKNOWN, G7 OSSEOTI 3 HOLE SHELL 48MM C. ZIMMER BIOMET PART # XL-200144, LOT # UNKNOWN, ACT ARTIC HD ARCOM XL 28X38MM. ZIMMER BIOMET PART # 110024461, LOT # UNKNOWN, G7 DUAL MOBILITY LINER 38MM C. ZIMMER BIOMET PART # 010000996, LOT # UNKNOWN, G7 SCREW 6.5MM X 15MM, QTY 5. ZIMMER BIOMET PART # 00489405815, LOT # UNKNOWN, TRABECULAR METAL¿ ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT. ZIMMER BIOMET PART # 30039400013, LOT # UNKNOWN, REFOBACIN BONE CEMENT R 1X40-3, QTY 3. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE STEM, HEAD, SHELL, DM LINER, AND SCREWS AFTER THE PATIENT HAD BEEN CREMATED. NO FURTHER EVALUATION CAN BE MADE DUE TO THE CREMATION DAMAGE. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LIMB LENGTH DISCREPANCY. AFTER REVIEW BY A HEALTH CARE PROFESSIONAL, THE PATIENT DEATH WAS DETERMINED TO BE NOT RELATED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: B5, B6, B7, D10, H6 ADDITIONAL HEALTH EFFECT - CLINICAL CODE. D10: UNK SPACER UNK. ZIMMER, BIOMET: (B)(6) UNK ECHO FX 9MM STD FEMORAL. (B)(6) UNK 28MM DIA COCR MOD HD -6MM NK. (B)(6) UNK G7 OSSEOTI 3 HOLE SHELL 48MM C. (B)(6) UNK TM ACETABULAR ACT AUGMENT. (B)(6) UNK G7 DUAL MOBILITY LINER 38MM C. (B)(6) UNK ACT ARTIC HD ARCOM XL 28X38MM. (B)(6) UNK G7 SCREW 6.5MM X 15MM X 5. (B)(6) UNK REFOBACIN BONE CEMENT R 1X40 X3.

    Additional Manufacturer Narrative · 0

    (B)(6). G2: FOREIGN - EVENT OCCURRED IN MEXICO. H6: PROPOSED COMPONENT CODE : MECHANICAL (G04) - STEM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP SURGERY. SUBSEQUENTLY, THE PATIENT EXPIRED APPROXIMATELY TWO (2) WEEKS LATER. THE SURGERY STARTED AT 2:00 PM. THE SURGEON INFORMED THE PATIENT¿S DAUGHTERS THAT THEIR FATHER HAD MUSCLE ATROPHY AND THAT HE HAD TO PERFORM SEVERAL MANEUVERS TO PLACE THE PROSTHESIS. HE ALSO MENTIONED THAT THE IMPLANT SIZE WAS NOT IDEAL, RESULTING IN ONE LEG BEING ONE CENTIMETER SHORTER, BUT SAID IT COULD BE CORRECTED WITH A SHOE LIFT. THE PATIENT WOKE UP AT AROUND 11:00 PM, FEELING VERY HOT. HE WAS GIVEN HALDOL TO CALM HIM DOWN, BUT HIS DAUGHTERS REPORTED THAT HIS EYES ROLLED BACK AND HE FELL ASLEEP. HE NEVER WOKE UP AGAIN. THREE (3) DAYS AFTER THE SURGERY, THE FAMILY WAS INFORMED THAT HE HAD SUFFERED SEVERE BRAIN DAMAGE AND WOULD NOT RECOVER. HE THEN PASSED AWAY ELEVEN (11) DAYS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643478 ECHO FX 9MM STD FEMORAL PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| D