BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGMENTAL FLUTED STEM EXTENSION

    MDR report key: 19714776 · Received July 10, 2024

    Report

    Report Number
    0001822565-2024-02317
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024197725
    PMA / PMN Number
    K101296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: ZSS DISTAL FEMORAL XT COMPONENT, CATALOG #: 00585004302, LOT #: 65346318; STEM COLLAR 35 MM O.D., CATALOG #: 00585204035, LOT #: 65299919; SIZE 3 PRECOAT NON-MODULAR CEMENTED TIBIAL COMPONENT, CATALOG #: 00588000302, LOT #: 64429075; SEG DIST FEM POLY BOX SZ C, CATALOG #: 00-5850-013-96, LOT #: 65473912; PRC TIB BLOCK 5MM SZ4, CATALOG #: 00-5988-004-26, LOT #: 64678239; PRC TIB BLOCK 5MM SZ4, CATALOG #: 00-5988-004-26, LOT #: 64632306; ALL POLY PAT COMP 38DIA, CATALOG #: 00-5972-065-38, LOT #: 64843454; PSN 2.5MM FEMALE SCR 25MM 2PK, CATALOG #: 42-5099-025-25, LOT #: 65390791; HEADLESS TROCAR DRILL PIN 75MM, CATALOG #: 00-5901-020-00, LOT #: 65396809; PSN 2.5MM FEMALE SCR 25MM 2PK, CATALOG #: 42-5099-025-25, LOT #: 65382100; SEG FLUTED STEM 11X130MM STR, CATALOG #: 00-5852-050-11, LOT #: 65384597; SEGMENTAL ART SURF SZ C 26MM, CATALOG #: 00-5850-030-26, LOT #: 63125154. G2: AUSTRALIA. H6: MECHANICAL (G04) - STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTS ARE ASSEMBLED WITH FOREIGN MATERIAL ON THEIR SURFACES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. X-RAY REVIEW INDICATES THERE IS HINGED PROSTHESIS RIGHT TOTAL KNEE ARTHROPLASTY WITH LOOSENING OF THE FEMORAL COMPONENT 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 PATIENT UNDERWENT A REVISION PROCEDURE EIGHTEEN MONTHS POST IMPLANTATION DUE FEMORAL LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040794 SEGMENTAL FLUTED STEM EXTENSION PROSTHESIS KNEE LZO ZIMMER BIOMET, INC. N/A 65384597 00889024197725

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| H