BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME

    MDR report key: 10659627 · Received October 9, 2020

    Report

    Report Number
    3010536692-2020-00651
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 19, 2024
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    UDI-DI
    M684PHAC12541
    PMA / PMN Number
    K091423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DESCRIPTION TO INCLUDE MHRA-UK REPORT NUMBER.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE STEM. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. COMPONENT NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM PRODUCT ID : PHA06262 LOT ID: 1504885. MHRA REFERENCE NO: (B)(4).

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE STEM. REVISION NJR NUMBER: (B)(6). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. COMPONENT NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM, PRODUCT ID: PHA06262, LOT ID: 1504885. MHRA REFERENCE NO: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 06/18/2021 FROM LEGAL DEPARTMENT: PATIENT'S NAME PROVIDED, DOB ((B)(6) 1967), REVISION SURGERY DOCTOR'S NAME, REASON FOR REVISION: ALLEGEDLY, PATIENT REVISED DUE TO THE PROFEMUR MODULAR NECK SUDDENLY FRACTURED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE STEM. REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY. COMPONENT NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 52MM. PRODUCT ID : PHA06262, LOT ID: 1504885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124392 PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. PHAC1254 1503097 M684PHAC12541

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention