Diaphyseal Sleeve Recall
In February 2013, the U.S. Food and Drug Administration issued a Class I recall of the DePuy LPS Diaphyseal Sleeve. This is the FDA’s most serious kind of recall. It applies only to situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
A month earlier, DePuy Orthopaedics, the device’s manufacturer, had issued its own recall.
The DePuy LPS Diaphyseal Sleeve is a device used in reconstructive knee surgery. It allows surgeons to reconstruct severe soft tissue and bone defects. The diaphysis is the midsection of a long bone. The “LPS” in the product’s name stands for “limb preservation system.” The diaphyseal sleeve is used to enhance the fit and fill of the diaphyseal femoral canal in procedures to reconstruct portions of the femur and tibia.
But the FDA says the device may not bear the weight of the person it is implanted in. As a result, the diaphyseal sleeve can fracture, leading to a loss of function, loss of limb, infection, compromised soft tissue or death.
The recalled medical devices were manufactured from 2008 to July 20, 2012. They include all lots issued under the following product numbers: 1987-20-018, 1987-20-020, 1987-20-024 and 1987-20-028.
What Should Hospitals and Surgeons Do?
Hospitals and surgeons should stop distributing or using the recalled lots, both DePuy and the FDA said in their separate recall notices.
In its notice to surgeons and orthopedists, DePuy does not recommend revision surgery to replace its recalled medical product or any follow-up procedure unless patients complain of problems. DePuy does recommend advising patients of the potential for the LPS Diaphyseal Sleeve to fracture and to tell patients how to recognize that a problem exists.
A patient who experienced an LPS Diaphyseal Sleeve failure without further complications would need revision surgery to replace the faulty device and/or repair additional damage to bone and soft tissue.
The recall of the DePuy LPS Diaphyseal Sleeve will keep additional patients from receiving this allegedly malfunctioning medical product. However, it does not help those who have already received the surgical implant. They can still suffer the potentially deadly consequences of the device’s failure, including the risk of additional revision surgery.
Contact a DePuy LPS Diaphyseal Sleeve Recall Lawyer
What Should You Do?
If you or a loved one received a DePuy LPS Diaphyseal Sleeve during knee reconstruction surgery, you should act to protect your rights now. An experienced defective medical device attorney can explain your legal options.
Contact The Driscoll Firm, LLC, by calling our toll-free number or using our online contact form.
Our legal team has helped individuals and families across the country whose lives were impacted by faulty medical devices, including surgical implants. John J. Driscoll, the firm’s founding lawyer, is a member of the Million Dollar Advocates Forum and the Multi-Million Dollar Advocates Forum.
The Driscoll Firm, LLC, can help you to obtain compensation to help defray the costs of your medical expenses, including revision surgery, lost income and other losses. We can also obtain funds to compensate you for your pain and suffering. Learn more by contact us today.
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