BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZSS DISTAL FEMORAL XT COMPONENT

    MDR report key: 19018719 · Received April 2, 2024

    Report

    Report Number
    0001822565-2024-01118
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00889024195950
    PMA / PMN Number
    K150028
    Removal / Correction Number
    N/A
    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: FLUTED STEM EXTENSION CATALOG # 00585205011, LOT # 65384594. 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. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2024-00094 AND 0001822565-2024-01119.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H11. H6: MECHANICAL (G04) - FEMUR. 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 AT THIS TIME.

    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
    1594592 ZSS DISTAL FEMORAL XT COMPONENT PROSTHESIS KNEE KRO ZIMMER BIOMET, INC. N/A 65346318 00889024195950

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| H SEE H10 NARRATIVE