The FDA has announced a Class I Recall for the modular neck component of a hip joint replacement system made by Shanghai, China-based MicroPort Orthopedics.
MicroPort Modular Neck Recalled
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The recalled product is the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. The affected lots of the modular neck were manufactured and distributed from mid-June 2015 to the end of July 2015. Over 10, 800 devices are part of the recall.
MicroPort sent a letter to distributors and hospital staff on August 7, 2015 notifying them of the voluntary recall. The company advised healthcare professionals to review the notice, locate all affected product, discontinue distribution and use of the devices and return the recalled product to its Arlington, Texas-based distribution center.
Unexpected Rates of Fracture
The reason for the recall, according to an October 2, 2015 FDA web posting, is that company 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.
Patients with the devices should continue to follow-up with their doctors as prescribed by their surgeon, and should seek treatment immediately if they experience any sudden onset of severe hip pain, difficulty walking, trauma to the hip or leg, or tingling or loss of feeling in their leg.
Hip implants continue to cause problems for some device makers. In February, Johnson & Johnson’s DePuy Synthes added $420 million to its $2.5 billion legal pot to resolve claims over recalled hip implants.
Then in June, Smith & Nephew plc pulled some hip implant sizes and related components from the market after data from the U.K.’s cost-effectiveness watchdog found that smaller sizes of the system had higher revision rates than expected.
Providers with questions are encouraged to e-mail cathy.park@ortho.microport.com.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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