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August 7, 2015: PROFEMUR Modular Neck Recall Due to Fracture Risk

PROFEMUR Modular Neck Recall News

MicroPort Orthopedics Inc. recalled the PROFEMUR modular neck after having received reports of an unexpected rate of fracturing in the device. MicroPort Orthopedics’s PROFEMUR modular neck is part of a hip joint replacement system, used during total hip replacement surgery.

In a total hip replacement surgery the damaged portions of the hip joint are removed and replaced with prosthetic parts; the PROFEMUR modular neck is a prosthetic hip joint replacement. However, if the PROFEMUR neck fractures, the patient may experience sudden pain and difficulty walking.

PROFEMUR Modular Neck Recall Due To Risk of Injury

The PROFEMUR modular neck recall was rated as a “Class I Recall” by the Food and Drug Administration (FDA), which is “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 death.”

Should the PROFEMUR fracture, the patient would require revision surgery to remove and replace the neck and stem components. Between the fracture and the emergency surgery, the patient would face a significant risk of neurovascular damage, hematoma, hemorrhage, or death.

OBTAIN A FREE PROFEMUR MODULAR NECK MEDICAL DEVICE LAWSUIT EVALUATION

If you are a loved one has been seriously injured by a faulty hip joint replacement device, and you have a question concerning your legal rights, please submit our easy-to-use “Legal Case Evaluation Form”, or contact us toll free at 1-877-934-6274 for a free legal case evaluation.

PROFEMUR Modular Neck Recall Details

In the U.S., 10,825 devices were included in the PROFEMUR Modular Neck recall. All lots of “PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254” are included in the recall.

The affected devices were manufactured between June 15, 2009 and July 22, 2015, and distributed between June 15, 2009 and July 31, 2015.

To get more information on the recall and to see instructions for distributors, hospital staff, and patients,
visit the FDA Medical Device Recall Announcement.

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