BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO BI-METRIC

    MDR report key: 22722647 · Received August 5, 2025

    Report

    Report Number
    0001825034-2025-02363
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 8, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00887868260599
    PMA / PMN Number
    K070274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6; H10. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE BROKEN CERAMIC HEAD, COVERED IN BIO-DEBRIS. NO FURTHER EVALUATION CAN BE MADE. PICTURES OF THE OTHER DEVICES WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED. REVIEW IDENTIFIED THE FOLLOWING: AN INITIAL LEFT THA WAS PERFORMED. THE PATIENT THEN PRESENTED WITH PAIN AND ELEVATED INFLAMMATORY MARKERS THAT CONFIRMED THE PRESENCE OF A CHRONIC PROSTHETIC JOINT INFECTION. A REVISION OCCURRED, WHERE IT WAS IDENTIFIED THE HEAD WAS DISASSOCIATED FROM THE STEM AND ALSO FRACTURED. ANY NECROTIC TISSUE WAS DEBRIDED, WITH SCARRING NOTED IN THE FASCIAL LAYER. ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH NO COMPLICATIONS NOTED. IMAGES ASSESSED, NOT SENT TO MMI GIVEN THE DETAIL PROVIDED IN THE REVISION OP NOTES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE STEM AND HEAD DISASSOCIATION. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. THIS COMPLAINT IS CONFIRMED. 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: CAT: 30104006 LOT: 66164028 40MM I.D. SIZE F NEUTRAL LINER, CAT: 00625006520 LOT: J7572531 BONE SCREW SELF-TAPPING , CAT: 00625006515 LOT: J7583493 BONE SCREW SELF-TAPPING, CAT: 802804003 LOT: 3123307 FEMORAL HEAD, H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS RETAINED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION, PAIN, INFLAMMATION, AND HEAD AND TRUNNION DISASSOCIATION DEMONSTRATED ON X-RAYS. DURING THE REVISION THE HEAD WAS CONFIRMED FRACTURED, THERE WAS SIGNIFICANT SCAR TISSUE, AND NECROTIC TISSUE WAS DEBRIDED FROM THE CUP. ALL COMPONENTS REVISED AND A CEMENT SPACER IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741319 ECHO BI-METRIC PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. 696900 00887868260599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H