The DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is used to stabilize the femur in patients who have suffered multiple fractures of the thighbone. However, evidence suggests that this device is associated with a high rate of failure that requires additional surgery to repair and replace the implant.
DePuy obtained regulatory clearance to sell the VA-LCP Curved Condylar Plate in 2009 via the U.S. Food & Drug Administration’s (FDA) 510k program.
Under this program, a device manufacturer does not have to conduct human clinical trials if it can be demonstrated that a new product is “substantially equivalent” to an older device that had previously undergone the agency’s strict premarket approval process, which does require human testing.
The DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is designed to treat distal femur fractures, a type of fracture that occurs on the thighbone just above the knee.
Orthopedic surgeons may choose among several device options to repair these fractures:
Distal femur fractures are very difficult to treat because of the shape of the thighbone. For this reason, locking compression plates have are becoming an increasingly popular option for repairing these types of breaks.
The DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is made of stainless steel and titanium alloy. A series of predrilled holes run its length. A portion of the plate is curved so that it can fit around the rounded edge of the thighbone – the condylar – where the femur meets the knee.
During surgery, special screws are used to affix the condylar plate to the fractured pieces of the femur, so that the bone remains stable as it heals.
A growing body of evidence suggests that the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate is associated with a high rate of breakage and failure. Failure of the plate can result in severe disability and the need for revision surgery to remove and replace the device.
For example, between 2011 and January 2018, the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database had received 200 reports in relation to the VA-LCP Curved Condylar Plate, including many that involved plate breakage and fracture.
A study published in the January 2016 issue of the Journal of Orthopaedic Trauma reported that the rate of premature failure associated with the Synthes variable angle locking compression plate (VA-LCP) was significantly higher compared to another type of plate and occurred more frequently with certain types of fractures. The authors of the study cautioned “against the use of this plate for metaphyseal fragmented distal femur fractures.”
Another study presented in March 2017 at the Orthopaedic Research Society’s annual conference described similar failures involving the DePuy Synthes 4.5mm VA-LCP Curved Condylar Plate.
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