BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    HIP-OTHER-STEM-UNK

    MDR report key: 22435128 · Received July 8, 2025

    Report

    Report Number
    0001822565-2025-02398
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 18, 2024
    Report Date
    April 9, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ STEM. B3: EVENT DATE IS THE PUBLICATION DATE OF THE ARTICLE. G2: BECKERS G, MORCOS MW, LAVIGNE M, MASSÉ V, KISS MO, VENDITTOLI PA. EXCELLENT RESULTS OF LARGE-DIAMETER CERAMIC-ON-CERAMIC BEARINGS IN TOTAL HIP ARTHROPLASTY AT MINIMUM TEN-YEAR FOLLOW-UP. J ARTHROPLASTY. 2024 DEC;39(12):3028-3035. DOI: 10.1016/J.ARTH.2024.06.045. EPUB 2024 JUN 22. PMID: 38909852. G2: FOREIGN: CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS 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

    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 (B)(6) 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. X-RAY IMAGES ARE PROVIDED WITHIN THE JOURNAL ARTICLE; HOWEVER IT IS UNKNOWN IF THEY ARE RELATED TO THIS PATIENT. 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. UNABLE TO CONFIRM COMPLAINT. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.

    Description of Event or Problem · 0

    THE STUDY REPORTED 1 PATIENT WAS REVISED DUE TO PROBABLE DEEP CHRONIC INFECTION AT 8 YEARS POSTOP DIAGNOSED BY SEVERE FEMORAL OSTEOLYSIS WITHOUT IDENTIFIED MICROORGANISMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438364 HIP-OTHER-STEM-UNK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. UNK

    Patients

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