BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR STEM

    MDR report key: 18688148 · Received February 12, 2024

    Report

    Report Number
    3006721341-2024-00003
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 11, 2024
    Report Date
    February 12, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM SURGEON 18-JAN-2024 SUGGESTS THAT THE DESIGN OF THIS CONE AND STEM CONSTRUCT MAY NOT HAVE BEEN WELL SUITED FOR THIS PATIENT. THE SURGEON NOTED ON 18-JAN-2024 THAT THE CONES ADDRESS METAPHYSEAL AREA BUT DO NOT ADDRESS META-DIAPHYSEAL INGROWTH, ESPECIALLY WHEN USED WITH CEMENTLESS STEMS (AS IN THIS CASE). THE SUBJECT COMPONENTS WERE IMPLANTED BY DR. M DURING REVISION KNEE SURGERY ON (B)(6) 2022. PATIENT COMPLAINED OF PAIN LOCATED IN MEDIAL AND LATERAL RIGHT KNEE STARTING AFTER SURGERY. DUE TO PAIN AND FEMORAL STEM LOOSENING, THE PATIENT'S KNEE WAS REVISED ON (B)(6) 2024. FEMORAL SIDE IMPLANTS WERE REPLACED WITH CUSTOM-MADE FEMORAL STEM (LBIO REF: (B)(4); WL REF: CASE 2023_0468), AND STANDARD ITEMS 15-8521/10 (TOTAL CONDYLAR REPLACEMENT) AND 15-0027/15 (REPLACEMENT PLATEAU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298029 MODULAR STEM MODULAR STEM KRO WALDEMAR LINK GMBH & CO. KG 15-8522/57 2130188

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention