BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 15MM X 150MM

    MDR report key: 17552838 · Received August 15, 2023

    Report

    Report Number
    0001825034-2023-01897
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 21, 2023
    Report Date
    December 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304238878
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6 - COMPONENT CODE - PROPOSED CODE IS MECHANICAL (G04) - STEM. 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 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM POLY LOCK PIN CATALOG #: 150478 LOT #: 395950, ORTHOPAEDIC SALVAGE SYSTEM 4CM DIAPHYSEAL SEGMENT CATALOG #: 150482 LOT #: 640430, ORTHOPAEDIC SALVAGE SYSTEM 7CM SEGMENTAL FEMORAL COMPONENT RIGHT CATALOG #: 150354 LOT #: 782310, ORTHOPAEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 79MM CATALOG #: 150424 LOT #: 689560, SERIES A 3 PEG PATELLA THIN 37MM X 8.6MM CATALOG #: 184788 LOT #: 277320, ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BEARING 16MM CATALOG #: 150412 LOT #: 622440, ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 293580, ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHINGS CATALOG #: 150477 LOT #: 096430, ORTHOPAEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 942420, ORTHOPAEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING CATALOG #: 150476 LOT #: 540910 THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES WERE DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2023-01892, 0001825034-2023-01896, 0001825034-2023-01898, 0001825034-2023-01899, 0001825034-2023-01900, 0001825034-2023-01901, 0001825034-2023-01903, 0001825034-2023-01904, 0001825034-2023-01905, 0001825034-2023-01906. H3 OTHER TEXT : INVESTIGATION INCOMPLETE.

    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 THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE INSTABILITY AND BONE PRESERVATION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198170 ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 15MM X 150MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 055900 00880304238878

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.