BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM 3CM RESURFACING FEMORAL COMPONENT RIGHT

    MDR report key: 21282626 · Received January 31, 2025

    Report

    Report Number
    0001825034-2025-00237
    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

    (B)(4). D11 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 739360, 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 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.

    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. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - FEMUR 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.

    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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150977 ORTHOPAEDIC SALVAGE SYSTEM 3CM RESURFACING FEMORAL COMPONENT RIGHT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 756670

    Patients

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