BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM POLY LOCKING PIN

    MDR report key: 17571408 · Received August 18, 2023

    Report

    Report Number
    0001825034-2023-01927
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 10, 2020
    Report Date
    December 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00887868343933
    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

    (B)(4). D10 - CONCOMITANT DEVICES - ORTHOPAEDIC SALVAGE SYSTEM ELLIPTICAL DIAPHYSEAL SEGMENT 3CM CATALOG #: 150461 LOT #: 230920, ORTHOPAEDIC SALVAGE SYSTEM IM STEM WITH SCREW 17MM X 90MM CATALOG #: 150364 LOT #: 099860, ORTHOPAEDIC SALVAGE SYSTEM SEGMENTAL FEMORAL COMPONENT 7CM RIGHT CATALOG # 150354 LOT #: 782310, ORTHOPAEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 79MM CATALOG #: 150424 LOT #: 689560, SERIES A THIN 3-PEG PATELLA 37MM X 8.6MM CATALOG #: 184788 LOT #: 277320, ORTHOPAEDIC SALVAGE SYSTEM TIBIAL POLY BEARING 16MM CATALOG #: 150412 LOT #: 622440, ORTHOPAEDIC SALVAGE SYSTEM REINFORCED YOKE CATALOG #: 150493 LOT #: 293580, ORTHOPAEDIC SALVAGE SYSTEM POLY FEMORAL BUSHINGS 2PK CATALOG #: 150477 LOT #: 096430, ORTHOPAEDIC SALVAGE SYSTEM AXLE CATALOG #: 150480 LOT #: 942420, ORTHOPAEDIC SALVAGE SYSTEM POLY 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: 0001825034-2023-01928, 0001825034-2023-01929 .H3 OTHER TEXT : INVESTIGATION INCOMPLETE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE INSTABILITY AND REQUIRING A DIFFERENT LENGTH TO STABILIZE THE LEG ONCE AGAIN APPROXIMATELY SIX (6) MONTHS POST-OPERATIVELY. 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
    2073612 ORTHOPAEDIC SALVAGE SYSTEM POLY LOCKING PIN PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 816710 00887868343933

    Patients

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