Knee Replacement Complications
Periprosthetic fractures of the femur after total knee arthroplasty are a potentially serious complication. It may involve the distal femur, proxima tibia or the patella.
“The most common pattern involves the supracondylar area of the distal femur. Supracondylar periprosthetic fractures frequently occur above a well-fixed prosthesis, and risk factors include anterior femoral cortical notching and use of the rotational constrained implant. Periprosthetic tibial fractures are frequently associated with loose components and malalignment or malposition of implants. [Source: National Center for Biotechnology Information]
Defective Femur Bone Implants
In a study presented at the March 2017 Orthopaedic Research Society (ORS) annual conference, DePuy Synthes acknowledged a consistent pattern of plate failure through the combination hole at the level of comminution with the use of the Synthes VA-LCP Curved Condylar Plate for the management of AO type 33-A.3.3 fractures.
Another study performed in January 2016 by Tank et. al, published in the Journal of Orthopaedic Trauma, concludes: Early mechanical failure with the VA distal femoral locking plate is higher than traditional locking plates (LCP and LISS) for OTA/AO 33-C fractures.
The study by Tank et al went on to state: We caution practicing surgeons against the use of this plate for metaphyseal fragmented distal femur fractures.
The March 2017 study goes on to proclaim, “Our study is the first to investigate the biomechanical effects of screw-hole filling on construct fatigue life in the surgical management of distal femur fractures, and the results encourage further research on the biomechanical properties of different plate designs.”
However, a similar study was presented at the 2011 ORS annual meeting.
Instead of addressing these problems by pulling a dangerous and defective product from the market, DePuy Synthes opted to continue selling the VA-LCP implant, while hiding it’s dangers from surgeons and patients.
Failure of the VA-LCP
Failure of the VA-LCP causes severe pain, rendering the patient unable to walk and requires surgery for removal and replacement of the implant.
Patients suffer additional costs for hospitalization, medication, rehabilitation, home healthcare and lost wages, and are put at risk for complications of surgery and even death.
The overall mortality is 30% for non-periprosthetic (native) fractures and 46% for periprosthetic fractures. Thirty-day, 6-month, and 1-year mortality rates are 2%, 13% and 23%, respectively, for the native fracture group and 8%, 24% and 27%, respectively, for the periprosthetic fracture group.
Proving Negligent Design Defect
To prove negligent design defect, Plaintiffs must show that DePuy Synthes violated its duty of care by introducing a product into the marketplace, or continuing a previous tender, with actual or constructive knowledge that the variable angle locking plate [implant] is too harmful to be used by anyone for the management of distal femur fractures.
- DePuy Synthes acknowledged a study presented at the March 2017 ORS annual meeting documenting a consistent pattern of plate failure through the combination hole at the level of comminution (Figure 1) with the use of the Synthes VA-LCP Curved Condylar Plate for the management of AO type 33-A.3.3 fractures.
- Notably, the same failure pattern in this particular plate was reported and acknowledged by DePuy Synthes, by Tank et. al in the January 2016 issue of Journal of Orthopaedic Trauma. For comminuted metaphyseal fractures, biomechanical and clinical studies have shown the benefits of bridging the fracture site by a distance of two to three screw holes, thereby decreasing rigidity and allowing for subtle bending motion and increased healing by callus formation. However, stress during loading is concentrated at the open screw holes at fracture apex, and this is where plate failure is observed – specifically, at the periphery of the “honeycombed” holes used for VA screw placement. (Figure 3)
Early mechanical failure with the VA distal femoral locking plate is higher than traditional locking plates (LCP and LISS) for OTA/AO 33-C fractures. The mean time to failure in group VA was 147 days (range 24-401 days) and was significantly earlier (P=0.034) when compared with group LISS (mean 356 days; range 251-433 days).
We caution practicing surgeons against the use of this plate for metaphyseal fragmented distal femur fractures.
Excerpt taken from the ORS 2017 Annual Meeting Poster No. 2429 March 2017 “Discussion: The variable angle plate design is well-suited for the management of comminuted fractures of the distal femur; however, implant failure – specifically in the DePuy Synthes VA-LCP curved condylar plate – has been consistently observed at the VA locking holes when used for this purpose.”
Defective Product Definition
A product is said to be defective when it is not reasonably fit for the ordinary purposes for which such product was sold and intended to be used. A defective product is unreasonably dangerous to the user or consumer when it is dangerous to an extent beyond which would be contemplated by the ordinary user (consumer) possessing the knowledge of the product’s characteristics which were common to the community.
Civil 3260: “You must be satisfied by the greater weight of credible evidence to a reasonable certainty that: (1) the product was in defective condition; (2) the defective condition made the product unreasonably dangerous to persons or property.”
RECEIVE A FREE EVALUATION FROM EXPERIENCED JOINT REPLACEMENT ATTORNEYS
Defective joint replacement lawsuits are often complicated. You need experienced attorneys who know how to navigate the system, the ins-and-outs of medical lawsuits and joint replacement litigation. The highly-experienced attorneys at Nash & Franciskato have a long track record of successfully litigating defective orthopedic cases.
If you are experiencing Periprosthetic fractures of the femur after total knee arthroplasty, contact us today for a free, no-obligation case evaluation.