BEUDAMED
    FDA Recall Terminated

    PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

    Recall: Z-2942-2020 · Initiated July 31, 2020

    Recall

    Recall Number
    Z-2942-2020
    Event Number
    86153
    Firm
    MicroPort Orthopedics Inc.
    FEI Number
    3010536692
    Product Code
    LWJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 31, 2020
    Posted
    September 18, 2020
    Terminated
    April 16, 2024
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501

    Description

    PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component

    Reason

    MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.

    Action

    The firm initiated the recall by letter on 07/31/2020. The letter provide the following instructions: "Distributors: 1. Please immediately cease use and distribution of these products. 2. Please check your stock, including all consignment stock to immediately determine if you have any affected product. 3. Please complete the form on the last page of this notification and return the form and any affected products to MicroPort Orthopedics per the Actions section of this notification. 4. Please assist us by distributing this notification to all hospitals and surgeons in your territory and collecting and returning completed forms to MicroPort Orthopedics. NOTE: This notice will also be sent directly to the hospitals and surgeons, however they only need to complete the information once, either provided through the distributor or send directly back to MicroPort Orthopedics. Hospitals: 1. Please immediately cease use of these products. 2. Please complete the form on the last page of this notification and return the form and any affected products to MicroPort Orthopedics per the Actions section of this notification. Surgeons: 1. Please immediately cease use of these products. 2. You can continue to monitor your patients per your normal protocol. There are no diagnostic techniques which can predict an unexpected postoperative failure. 3. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. 4. Please sign and return this form per the instructions to confirm your notification of this action. ACTIONS: 1. Please complete and return the enclosed form immediately even if you do not have any affected product to return. This information is essential in order to carry out effectiveness checks required per FDA guidelines. Return the completed form by fax to: 901-867-4771, or by e-mail to: [email protected]. Please feel free to

    Distribution

    worldwide, except China and Japan

    Quantity

    556 units