Class I Recall Issued by FDA for DePuy Orthopedics Knee Revision Device
On February 15th, the FDA issued a Class I Recall – the most serious recall possible – against a DePuy Orthopedics knee revision device.
Per the FDA’s website, the LPS Diaphyseal Sleeve is intended for use with another DePuy Orthopedics device, the LPS System. The sleeve allows surgeons using the LPS knee replacement system to reconstruct soft tissue and bone that is severely damaged.
However, the FDA says of the defective device: “The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue or death.”
On January 4th, DePuy Orthopedics issued a voluntary recall of the device. The company, a subsidiary of Johnson & Johnson, informed surgeons and hospitals that they should send any stock of the LPS Diaphyseal Sleeve back to DePuy. The orthopedic device manufacturer also encouraged surgeons to communicate with patients who received these implants.
However, the FDA received a total of 10 reports of incidents in which the device malfunctioned. The agency issued the Class I Recall because serious health complications and possibly death could result from device failure.
If the device fails, patients could suffer the following serious side effects:
- Loss of function
- Loss of limb
- Compromised soft tissue
The recalled sleeves were manufactured between 2008 and 2012.
DePuy Orthopedics Faces Thousands of Personal Injury Lawsuits for Other Defective Medical Devices
DePuy Orthopedics, and Johnson & Johnson, face thousands of personal injury lawsuits for a slew of defective drugs and medical devices released in the last few years. J&J’s Ethicon division recently lost a bellwether trial lawsuit for its defective transvaginal mesh device. J&J’s DePuy Orthopedics is in the midst of a bellwether trial for its all-metal hip replacement devices, specifically the ASR and Pinnacle models. Witnesses have begun to testify in Loren Kransky’s personal injury bellwether trial against DePuy for his all-metal hip replacement device’s failure.
Defective Products, Such as DePuy’s Knee and Hip Devices, Can Cause Serious Personal Injury
Medical manufacturers such as DePuy Orthopedics must be held to the highest standard of excellence. Unfortunately, manufacturers of drugs and medical devices do not always test their products as strenuously as necessary, and consumer problems can go unnoticed, despite reports to the manufacturer and the FDA, can go unnoticed for years.
There are a number of reasons that defective products make it to our shelves:
- Defective manufacturing
- Inadequate testing
- Design defects
- Marketing Misrepresentation
To protect yourself and your family, it’s important to know what products have been recalled because they are defective or unsafe. Federal agencies such as the FDA (Food and Drug Administration) and the CPSC (U.S. Consumer Product Safety Commission) frequently issue recalls for medical devices, drugs, and products that may be harmful to consumers.
If you or a loved one has received a metal hip replacement device, specifically from DePuy Orthopedics, and have since suffered painful side effects, you may be entitled to compensation. The attorneys at the Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800.