DePuy had three strikes against its knee replacement system before the attorneys of Cunningham Bounds filed the DePuy Synthes Attune lawsuit.
1. The medical device company reported to the FDA a number of premature failures of the Synthes Attune knee that resulted in painful revision surgeries, and lengthy recovery times. And additional costs.
2. Nine prominent orthopedic surgeons reported in the Journal of Knee Surgery an unusually high rate of early failure of the tibial component in the Attune knee system at the implant-cement interface. Patients (with average age of 61 years—DePuy marketed this knee to a younger and more active demographic) complained of pain on weight bearing, effusion or swelling, and decreased range of motion within two years after surgery. DePuy also promoted this “novel design total knee arthroplasty (TKA) system” to improve patient outcomes and increase longevity, which typically lasts a minimum of 15 years. However, the surgeons said they “encountered a high rate of debonding of tibial implant–cement interface”. In other words, the glue didn’t stick, which caused the entire knee replacement to become destabilized.
In addition, the Journal noted that , “multiple reports have been filed in Manufacturer and User Facility Device Experience database (MAUDE) with the same mechanism of failure.”
3. A recall in June 2015 that involved 3,474 units was issued by the FDA for an Attune Knee Tibial Articulation Surface instrument.
Surgeons must measure the patient’s bones and range of motion before a knee implant can be inserted, to properly calibrate the device. A “trial” implant is used before any holes are drilled into the bone and with that trial implant comes a Balseal, a small wire spring coil used in the range of motion testing to aid in tibial location prior to drilling peg holes. But the Balseal easily became damaged and fell out during use, so the coil was able to enter the surgical site during the knee replacement surgery and remain in the patient if the surgeon forgot or was unaware that it had detached.
READ MORE DEPUY SYNTHES ATTUNE KNEE REPLACEMENT LEGAL NEWS
If your DePuy Synthes Attune knee is prematurely failing, consider filing a product liability lawsuit against the medical device manufacturer. It won’t be the first time that DePuy has been accused of marketing a defective device and faced subsequent lawsuits.