BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 17MM X 90MM

    MDR report key: 17571424 · Received August 18, 2023

    Report

    Report Number
    0001825034-2023-01930
    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
    00880304238923
    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 LOCKING PIN, CATALOG #: 150478, LOT #: 816710; ORTHOPAEDIC SALVAGE SYSTEM ELLIPTICAL DIAPHYSEAL SEGMENT 3CM, CATALOG #: 150461, LOT #: 230920; 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: 0001825034-2023-01927, 0001825034-2023-01928, 0001825034-2023-01929. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339335 ORTHOPAEDIC SALVAGE SYSTEM CEMENTED IM STEM 17MM X 90MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 099860 00880304238923

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.