BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALAVAGE SYSTEM STRAIGHT IM STEM WITH SCREW 11MM X 150MM

    MDR report key: 19891773 · Received August 2, 2024

    Report

    Report Number
    0001825034-2024-01963
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, G3, G6, H2, H3, H6, H11. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. RADIOGRAPHIC REVIEW CONFIRMED THAT THE LONG-STEM TIBIAL IMPLANT HAD FRACTURED THE TIBIA AND PROTRUDED THROUGH THE POSTERIOR TIBIAL CORTEX. 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). D10 - CONCOMITTANT DEVICES - ORTHOPEDIC SALVAGE SYSTEM POLY LOCK PIN, CATALOG #: 150478, LOT #: 66071388. ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE, CATALOG #: 150493, LOT #: 66294425. ORTHOPEDIC SALVAGE SYSTEM TIBIAL POLY BEARING 12MM, CATALOG #: 150410, LOT #: 66509083. ORTHOPEDIC SALVAGE SYSTEM POLY FEMORAL BUSHINGS, CATALOG #: 150477, LOT #: 66521390. ORTHOPEDIC SALVAGE SYSTEM AXLE, CATALOG #: 150480, LOT #: 66097377. ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL LOCK SCREW SET, CATALOG #: 150481, LOT #: 798520. ORTHOPEDIC SALVAGE SYSTEM POLY LOCK PIN, CATALOG #: 150478, LOT #: 66118825. ORTHOPEDIC SALVAGE SYSTEM SEGMENTAL FEMORAL COMPONENT RIGHT 7CM, CATALOG #: 1150354, LOT #: 66458899. ORTHOPEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 67MM, CATALOG #: 150421, LOT #: 894010. ORTHOPEDIC SALVAGE SYSTEM POLY TIBIAL BUSHING, CATALOG #: 150476, LOT #: 65769917. G2 - REPORT SOURCE - FOREIGN: EVENT OCCURRED IN AUSTRALIA, THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 ONE DAY FOLLOWING KNEE ARTHROPLASTY, A POST-OPERATIVE X-RAY IDENTIFIED THAT THE PATIENT'S TIBIAL STEM WAS PROTRUDING THROUGH THE POSTERIOR CORTEX OF THE TIBIA. THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO CORRECT THE ISSUE A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958723 ORTHOPEDIC SALAVAGE SYSTEM STRAIGHT IM STEM WITH SCREW 11MM X 150MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 054720

    Patients

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