BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM AXLE

    MDR report key: 21282675 · Received January 31, 2025

    Report

    Report Number
    0001825034-2025-00241
    Event Type
    Injury
    Date Received
    January 31, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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: B4, D4, G3, G6, H2, H3, H4, H6, H11. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D11 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493, LOT #: 146220, ORTHOPAEDIC SALVAGE SYSTEM NON-MODULAR PROXIMAL TIBIAL COMPONENT 5CM 13X150, CATALOG #: 150437, LOT #: 742230, ORTHOPAEDIC SALVAGE SYSTEM POLY LOCK PIN CATALOG #: 150478, LOT #: 025790, ORTHOPAEDIC SALVAGE SYSTEM 3CM RESURFACING FEMORAL COMPONENT RIGHT CATALOG #: 150350, LOT #: 756670, ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING CATALOG #: 150476, LOT #: 958290, ORTHOPAEDIC SALVAGE SYSTEM POLY FEMORAL BUSHINGS CATALOG #: 150477, LOT #: 071280, ORTHOPAEDIC SALVAGE SYSTEM POLY TIBIAL BEARING 22MM CATALOG #: 150415, LOT #: 874450, ORTHOPAEDIC SALVAGE SYSTEM CEMENTED INTRAMEDULLARY STEM 14MM X 150MM, CATALOG #: 150368, LOT #: 451150. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE PATIENT EXPRESSED NEEDING MEDICAL ATTENTION APPROXIMATELY FIFTEEN (15) YEARS FOLLOWING RIGHT KNEE ARTHROPLASTY TO ADDRESS UNKNOWN COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462500 ORTHOPAEDIC SALVAGE SYSTEM AXLE PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 739360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SEE H11 NARRATIVE.