BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME

    MDR report key: 13590538 · Received February 24, 2022

    Report

    Report Number
    3010536692-2022-00054
    Event Type
    Injury
    Date Received
    February 24, 2022
    Report Date
    April 1, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JDI
    UDI-DI
    M684PHAC12541
    PMA / PMN Number
    K091423
    Removal / Correction Number
    Z-2743-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE - STEM REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: FIT AND HEALTHY. COMPONENTS FROM OTHER MANUFACTURER THAT WERE REVISED: CENATOR CUP 28X48 NEUT LGE FLG PRODUCT ID: 176848/ LOT NO.: 306444.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE - STEM REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: FIT AND HEALTHY. COMPONENTS FROM OTHER MANUFACTURER THAT WERE REVISED: CENATOR CUP 28X48 NEUT LGE FLG PRODUCT ID: 176848/ LOT NO.: 306444.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330156 PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME HIP COMPONENT JDI MICROPORT ORTHOPEDICS INC. PHAC1254 1573870 M684PHAC12541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention