On August 1, 2013, the FDA posted a Class 1 device recall notice for a DePuy Orthopaedics, Inc. femur device component. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
DePuy Recalls Femur Component
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Secondary
LPS Lower Extremity Dovetail Intercalary Component
The agency and the company have notified healthcare professionals of the recall of the LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking.
This fracture may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury or need for revision surgery. Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture.
The LPS Lower Extremity Dovetail Intercalary Component is intended for replacement of the mid-shaft portion of the femur, top (proximal), bottom (distal) and/or total femur, and top (proximal) tibia, especially in cases that require extensive resection (i.e., tumors, trauma, infections, etc.).
DePuy issued an Urgent Medical Device Recall on July 11, 2013, alerting distributors, hospitals and surgeons of the problem, asking them to immediately stop distributing or using the recalled lots. These products were manufactured and distributed from February 2007 through May 2013.
The company is providing a patient letter template to assist surgeons with notifying and discussing the risks of the implant fracture and the method for detecting implant failure with their patients. DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.
Surgeon Options
If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary Component with well-fixed proximal and distal stems and the surgeon determines that replacing the LPS Lower Extremity Dovetail Intercalary Component is the best treatment option, DePuy will make the LPS Lower Extremity Dovetail Intercalary Component available. If the LPS Lower Extremity Dovetail Intercalary Component has fractured and the surgeon determines that the replacement LPS Lower Extremity Dovetail Intercalary Component is not the best treatment option for a patient, other commercially available products should be considered.
Questions should be directed to Kim Earle, DePuy’s Recall Coordinator at 574-371-4917, Monday through Friday from 8 am to 5 pm Eastern Time.
Read the complete FDA recall notice for further recommendations and a list of affected product codes and lot numbers.
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Discussion
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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