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U.S. Department of Health and Human Services

Class 1 Device Recall PROFEMUR Neck Long Titanium

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  Class 1 Device Recall PROFEMUR Neck Long Titanium see related information
Date Initiated by Firm July 31, 2020
Date Posted September 18, 2020
Recall Status1 Terminated 3 on April 16, 2024
Recall Number Z-2941-2020
Recall Event ID 86153
510(K)Number K003016  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Product Code LWJ
Product PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
Code Information All lots/serial numbers
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Rachael Wise
901-867-4771
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
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: PostMarket@ortho.microport.com. Please feel free to
Quantity in Commerce 123,284 units
Distribution worldwide, except China and Japan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LWJ and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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