Diaphyseal Sleeve Complications
The DePuy LPS Diaphyseal Sleeve is used in reconstructive knee surgery. In January 2013, the U.S. Food and Drug Administration (FDA) issued a Class I recall of this product – the most serious kind of recall – due to the possibility that the sleeve could fracture when a patient puts their full weight on the knee and tries to walk after surgery.
According to the FDA, this fracture can lead to a series of complications, or side effects, which can best be described as “cascading injuries.” In other words, one injury can lead to or compound the effects of another injury.
The FDA says the complications include:
- Infection – Surgical site infections (SSIs) are common and potentially deadly. Some reports have said that one-third of postoperative deaths are related, at least partially, to SSI. A severe infection can lead to shock, heart failure and other causes of death.
- Compromised soft tissue – As pieces of the fractured sleeve fall away with movement of the patient’s knee and leg, they can become lodged in surrounding soft tissue, including muscle, tendons and ligaments. This damage weakens the soft tissue and opens it to infection.
- Loss of function or loss of the limb – As damage to muscle, tendons and ligaments progresses, the patient’s ability to move his or her leg without pain or to move it at all is likely to decrease. In cases of severe damage to soft tissue and bone, the limb may be subject to amputation.
- Death – Infection can lead to death if it is not treated in a timely manner. Surgical site infections (SSIs) that spread to the compromised soft tissue can infect the blood (sepsis), which is a serious and potentially deadly problem.
Revision surgery would be necessary to remove a faulty LPS Diaphyseal Sleeve, but DePuy is not recommending removal of their recalled medical product unless patients experience problems.
Contact a DePuy LPS Diaphyseal Sleeve Recall Attorney
DePuy’s recall of its LPS Diaphyseal Sleeve will protect additional patients from receiving this allegedly faulty medical product. But the recall does little for patients who have already received the surgical implant. These knee reconstruction surgery patients may yet suffer the potentially deadly consequences of the device’s failure.
If you or a family member of yours has received a DePuy LPS Diaphyseal Sleeve during knee reconstruction surgery, you have legal rights. You should act now to protect them. A lawyer with experience litigating defective medical device claims can explain your legal options.
Contact The Driscoll Firm, LLC, through our online contact form or by calling our toll-free number. You may be eligible to obtain compensation for medical expenses, including the costs of revision surgery to remove the diaphyseal sleeve. You may also seek money to compensate for your lost income, pain and suffering and other harm you have suffered.
For more information:
- DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall, U.S. Food and Drug Administration
- Medical Devices Recall – DePuy Orthopaedics, Inc. – LPS Diaphyseal Sleeve, U.S. Food and Drug Administration
- Surgical Site Infection: Prevention and Treatment of Surgical Site Infection, National Collaborating Centre for Women’s and Children’s Health (UK)