The FDA has issued the following recall which can be found at:
Duck Law Firm, LLC represents claimants with
defective hip implants. The last client we represented in connection with a hip implant recall
recovered over $500,000.
MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part
number PHAC 1254
Recall Class: Class I
Date Recall Initiated: August 7, 2015
Product: PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254
- All lots are affected
- Manufactured from: June 15, 2009 to July 22, 2015
- Distributed from: June 15, 2009 to July 31, 2015
- Devices Recalled in the U.S.: 10,825
Use: MicroPort Orthopedics has a variety of hip joint replacement systems that
allow the surgeon to fit the implant specifically to the patient. During
total hip replacement surgery, the damaged portions of the hip joint are
removed and replaced with prosthetic parts including a femoral head, femoral
stem and modular neck. The PROFEMUR Neck Varus/Valgus CoCR, part number
PHAC1254 is the modular neck being recalled.
MicroPort Orthopedics, Inc.
5677 Airline Road
Arlington, TN 38002
Reason for Recall: MicroPort Orthopedics Inc. has received reports of an unexpected rate
of fractures after surgery related to this specific modular neck. If the
modular neck fractures, the patient may experience sudden pain, instability
and difficulty walking and performing common task. An acute fracture will
require revision surgery to remove and replace the neck and stem components.
Acute fracture and emergency revision surgery is a serious adverse health
consequence and could lead to neurovascular damage, hematoma, hemorrhage,
and even death.
Public Contact: Questions should be directed to MicroPort Orthopedics Inc.’s Customer
Experience Department at 1-866-872-0211, Monday through Friday, between
the hours of 7:30 a.m. and 7:30 p.m. Central Standard Time.
FDA District: New Orleans District Office
More Information about this Recall:
On August 7, 2015, MicroPort Orthopedics Inc. informed distributors and
hospital staff of a
voluntary device product recall.
Instructions for distributors and hospital staff including risk managers
and surgeons: The following instructions were provided:
- Review the notification and ensure affected personnel are aware of the recall.
- Locate all affected product identified in the recall letter.
- Stop using and distributing the affected product.
- Return the recalled product to MicroPort Orthopedics Inc. Distribution
Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping
boxes with "RECALL" on several sides for better identification
Regardless of whether you have the affected product, complete and return
the Verification Form/Effectiveness Check by fax to 901-451-6032 or by
Instructions for patients:
- Patients should continue to follow up with their health care provider at
regular intervals as prescribed by their surgeon.
- There is currently no evidence that modular neck fractures can be anticipated
by patient history, physical exam, visual inspection or by using any imaging
modality including X-ray, MRI, or CT scans.
- Patients not experiencing symptoms should not take any further action.
- Patients should seek immediate medical treatment if they experience any
sudden onset of severe pain in their post-operative hip, difficulty or
inability walking, significant trauma to their hip or leg (e.g. falling),
or a tingling sensation or loss of feeling in their leg.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations
in which there is a reasonable probability that use of these products
will cause serious adverse health consequences or
Health care professionals and consumers may report adverse reactions or
quality problems they experienced using these products to the
MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.