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PROFEMUR Neck Varus/Valgus CoCr 8 Degree Recall

MicroPort Orthopedics, Inc. is a manufacturer acquired by Wright Medical Group. The company voluntarily recalled the PROFEMUR neck devices after it received reports of implant fractures requiring revision surgery.

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On August 7, 2015, MicroPort Orthopedics, Inc., voluntarily recalled one of its PROFEMUR modular neck devices, the PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254. A “modular neck” may be present in a prosthetic device implanted during total hip replacement surgery. 1

In its recall letter, MicroPort asked distributors and hospital staff to locate all affected products, stop using and distributing the specified PROFEMUR modular neck devices, and return the recalled products. 2

FDA Class 1 Recall of MicroPort’s PROFEMUR Neck

The U.S. Food and Drug Administration (FDA) has classified this recall of the PROFEMUR modular neck as a Class 1 recall, saying, “MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck.” If this implant fractures, a patient may require an “emergency revision surgery,” which is “a serious adverse health consequence [that] could lead to neurovascular damage, hematoma, hemorrhage, and even death.”

According to the FDA, “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.” 3

Patients with this recalled device “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.” 4

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Wright Medical Division Acquired by MicroPort Orthopedics

This device was originally manufactured by Wright Medical Group. Wright Medical Group is a company that produces a variety of medical devices including those for orthopedic repair, surgical use and diabetes. 5

Because the recall applies to these devices manufactured from June 15, 2009 to July 22, 2015, the recalled neck may have been manufactured by Wright, or by MicroPort Orthopedics, Inc.  In 2013, MicroPort Orthopedics, Inc., acquired Wright Medical Group, Inc.’s, OrthoRecon business, which was responsible for manufacturing PROFEMUR modular stems, as well as other medical devices.  MicroPort now owns and manufactures many of these devices under the MicroPort name. 6

During total hip replacement surgery in which a modular neck is used, “the damaged portions of the hip joint are removed and replaced with prosthetic parts including a femoral head, femoral stem, and modular neck.”

Hip Replacement Surgery Implants Prosthetic Hip Components

During total hip replacement surgery in which a modular neck is used, “the damaged portions of the hip joint are removed and replaced with prosthetic parts including a femoral head, femoral stem, and modular neck.” 7 A synthetic hip socket is also inserted. 8

A prosthetic hip joint attempts to replicate the natural hip joint. Generally, the prosthetic hip implant socket is made of a metal. A plastic or ceramic liner fits inside the socket. 9

A metal stem is inserted into the thighbone. In a modular neck device, a piece called the “neck” joins the metal stem to a ceramic or metal ball (round head) that is situated on top of the thighbone. This head moves within the hip socket liner. 10

Problems with Hip Implant Components

In recent years, researchers have explored the problems associated with total hip replacement parts, especially problems related to modular necks. These include metal corrosion, or release of metal debris, “adverse local tissue reactions,” mechanical failure, fractures, catastrophic failure resulting from an acute fracture at the “neck-stem juncture,” fretting, and loosening. 11

  1. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  2. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  3. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  4. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  5. http://www.microport.com.cn/en/media.php?curr_page=news_details&id=199 

  6. http://www.microport.com.cn/en/media.php?curr_page=news_details&id=199;
    http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  7. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm465501.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 

  8. https://www.nlm.nih.gov/medlineplus/ency/article/002975.htm; http://ortho.stanford.edu/arthritis-and-joint-replacement/total-hip-replacement.html 

  9. https://www.nlm.nih.gov/medlineplus/ency/article/002975.htm; http://ortho.stanford.edu/arthritis-and-joint-replacement/total-hip-replacement.html 

  10. https://www.nlm.nih.gov/medlineplus/ency/article/002975.htm; http://ortho.stanford.edu/arthritis-and-joint-replacement/total-hip-replacement.html 

  11. http://www.ncbi.nlm.nih.gov/pubmed/22113876; http://www.ncbi.nlm.nih.gov/pubmed/24267203; http://www.ncbi.nlm.nih.gov/pubmed/24631128; http://www.ncbi.nlm.nih.gov/pubmed/23823060; http://www.ncbi.nlm.nih.gov/pubmed/21798696; http://www.ncbi.nlm.nih.gov/pubmed/24090661; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2874667/; http://jbjs.org/content/92/6/1522