Philips announced a voluntary recall of some of its sleep and respiratory care devices in mid-June. The U.S. Food and Drug Administration (FDA) announced the…Read More
Failure of Device Used to Repair Fractured Thighbone
The news went from bad to worse. The doctor told you, you had broken your leg; specifically, the part of your thighbone a little above your knee. Then she showed you the X-rays.
The break in your bone was not simple or clean. In fact, the broken parts looked like fragments coming off your thighbone.
However, your doctor told you that you’d be able to walk again with the implantation of a device intended to stabilize the fracture.
The device your doctor implanted was called the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate. Your doctor said it was specifically intended for fractures like yours where there were multiple fragments of the thigh above the knee — what is called the distal femur.
You hoped everything would turn out fine. But it did not.
Device Failure Likely Requires Revision Surgery
At a follow-up checkup, perhaps just weeks after you underwent surgery, your doctor explained the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate device had fractured. Your doctor showed you the X-rays, and you could not understand how something like this could happen. But it had.
Your only option was to go through surgery all over again. And this time it would be even more complicated because your doctor would have to redo all the work that had already been done, as well as correcting any damage caused by the device.
Unfortunately, the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is linked to early fracturing and bending resulting in implant failure.
DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate Lawsuits
Weitz & Luxenberg is now accepting clients who received a DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate who needed to undergo a revision, or corrective, surgery due to bending or fracturing of this medical device. Or, if you have not yet undergone a revision surgery but your doctor advised you to undergo one, we invite you to contact us.
If you recently underwent surgery to repair a severe fracture of your thighbone above the knee (a distal femur fracture) because the bone had broken into several fragments, we urge you to contact your doctor to see if you received a DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate.
Additional Surgery Due to Distal Femur Device Fracture
If have already undergone or need to undergo a revision surgery due to early bending or fracturing of this device, you may be eligible to pursue legal compensation.
You may be entitled to compensation for:
- Medical expenses
- Any lost wages
- Other related costs
Ellen Relkin, W&L’s Drug & Medical Device Litigation Unit Practice Group Chair, works alongside other Weitz & Luxenberg attorneys to successfully handle complex medical device lawsuits, and has decided to pursue these cases.
“This device is particularly concerning because the plate may fracture without you knowing it: some patients simply start experiencing pain. A bent plate may show up only if the patient has X-rays taken, though this compromised hardware is putting the patient at risk of serious complications,” Ms. Relkin points out. She adds, “I hope anyone who was implanted with this device has seen a doctor and has undergone or is planning to undergo a revision surgery if they have had a break or bending of the plate. That is the only way to fix the problem.”
We can provide you with legal guidance regarding your options for pursuing compensation.
We offer a free consultation. Please call us at (833) 544-0604 to speak with one of our representatives. Or, if you prefer, you can submit the form on this page.
Device Used to Repair Severe Bone Fractures
When someone breaks a leg and the fracture occurs in the thighbone a little above the knee, doctors may choose the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate in an attempt to stabilize the fracture. The plate looks something like a metal
To attach the plate to the thighbone, doctors use types of metal screws. The plate has holes in it through which a surgeon attaches screws directly to the thighbone and knee.(2)
The plate contains multiple screw holes. Surgeons decide which and how many screw holes to use depending on the patient and the location and complexity of the fractures.(3)
DePuy Synthes Distal Femur Device Design
The DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate System has been approved by the FDA for “buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, and non-unions and malunions.”(4) (5) (6)
DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate Linked to Early Breaking, and Failing
Recent studies and adverse event reports suggest the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is linked to early mechanical failure. The plate itself can fracture or bend inside a patient under normal loading conditions (only supporting body weight).(7) (8) (9) (10)
When the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate bends or fractures, the device has failed. What that means for patients is that they need another surgery to remove the broken plate, repair any damage, and implant another device to fix the original broken thighbone.
What is particularly concerning is that the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system may fracture and fail just weeks after a patient has undergone surgery.(11)
DePuy Synthes Femur Bone Implant Compared to Others
Researchers of one study compared the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system and two other types of repair systems: a less invasive stabilization system (LISS) and a system using locking condylar plates (LCPs). They found the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system exhibited a significantly greater failure rate for certain types of fractures, as well as significantly earlier failure, compared to the other fracture repair systems.(12)
The researchers even cautioned surgeons against using the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system for “metaphyseal fragmented distal femur fractures.”(13)
The researchers of another study were curious if filling the unused open screw holes in the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system would prevent bending, fracturing, and early mechanical device failure. They found that filling these unused open screw holes did not make a difference, noting “the design leaves a thin section of plate near the outer edge of the hole which reproducibly fails under cyclic loading.”(14)
Device Problems Reported to FDA
According to the U.S. Food & Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database, the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate system is linked to hundreds of reports of pain, infection, and breaks and fractures. Breaks and fractures require revision surgery to correct.
Examples of complications described in the MAUDE database include:
- For one patient, the “plate was found to be broken, and it was discovered that the patient had developed a non-union, which reportedly led to the removing of the broken hardware.” The patient needed a revision surgery to remove the broken plate and implanted another plate using screws and a bone graft.(15)
- Another patient had to undergo a revision surgery because of a broken plate. Reportedly, the plate had broken into two clean pieces.(16)
- In another instance, a patient had surgery to treat a right distal femur fracture. Following the surgery, the patient presented with a broken plate. The patient required a revision surgery. The surgeon removed the broken device and implanted a longer variable angle locking plate and screws.(17)
W&L Helps with Complications from Device Failure
Were you implanted with a DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate after experiencing a fracture to an area of your thigh above your knee called the distal femur? If so, the attorneys at Weitz & Luxenberg encourage you to check with your doctor to see how the device is holding up if you are experiencing pain or inability to bear weight.
A break or fracture of the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate means the device failed. The only way to fix the problem is with a revision surgery.
At Weitz & Luxenberg, we are encouraging anyone who received this medical device and required a revision surgery to contact us. Our medical device attorneys may be able to help you.
You may be entitled to compensation. DePuy Synthes, the manufacturer of the 4.5mm VA-LCP Curved Condylar Plate, has not recalled this device, this particular medical plate system appears to be linked to bending and fracturing.
Device Failure Requires Revision Surgery
Bending or fracturing of the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is serious.
For those of you who may have received this device and have not yet undergone a revision surgery but are experiencing symptoms of pain or inability to bear weight, we urge you to check with your doctor to see if the device has failed. If it has failed, you should determine if you need to undergo a revision surgery. If you do, our medical device attorneys may be able to help.
Please do not hesitate to contact us. We may be able to file a defective medical device lawsuit against the manufacturer for its failing device. The manufacturer should be held responsible for costs you incurred to have the device removed and replaced.
In addition, you may be entitled to compensation for pain and suffering and loss of income if you were unable to work, as well as other related medical expenses.
Experience Winning Device Failure Lawsuits
Filing a lawsuit against a major medical device manufacturer may seem intimidating, but Weitz & Luxenberg can help you. We are a national law firm, and our attorneys have more than 30 years of experience handling complex medical device lawsuits.
We also have a solid history of winning. In fact, we have secured more than $17 billion dollars in verdicts and settlements on behalf of our clients.
Please, let us help you. We offer a free consultation and can assist you in evaluating your legal options.
Feel free to call us at (833) 544-0604 or fill out the form on this web page.
Although a past record does not guarantee future success, Weitz & Luxenberg has the experience and resources necessary to stand up to large-scale medical device manufacturers when their products fail and cause you pain and suffering.