DePuy Attune Knee Replacement Lawsuit
DePuy Attune Knee Problems
The DePuy Synthes Attune total knee arthroplasty (TKA) system has been the subject of hundreds of complaints to the FDA about the knee device’s problems. The DePuy Attune Knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. The failure seems to be related to the cement which holds the device in place.
Study of Attune Knee Replacement FDA Reports
The study, published by the Journal of Knee Surgery, examined Manufacturer and User Facility Device Experience reports (MAUDEs) made to the FDA by manufacturers, hospitals, doctors, patients, and consumers. In particular, it studied patients who received a DePuy Attune TKA, and later required revision surgery. In looking at three hospitals, the study found 15 cases of tibial loosening of the cement on the implant. Further, the study authors noted that there were 21 cases of tibial loosening reported to the FDA within the last two months alone. “Numerous other tibial failures” were reported without specifying how the failure occurred.
510(k) Fast Track Approval – Without Product Testing
The DePuy Attune knee system was fast-tracked by the FDA as DePuy represented to the FDA that the Attune knee system was “substantially similar” to devices on the market. The 510(k) FDA approval process allows manufacturers to skip doing clinical trials on a product because it is so close to a product already on the market. DePuy submitted to the FDA that the Attune knee system was substantially equivalent to the following existing knee system devices:
- PFC Sigma© Knee System (cleared as the Darwin Knee System), K943462
- Sigma Patella (cleared s the Darwin Knee System), K950010
- PFC Cruciate Retaining System, Size 1.5, K961685
- Sigma Co-Cr Tibial Trays, K032151
- Sigma XLK Tibial Inserts, K040166
- Sigma CR 150 Femoral Components, K082500
- Zimmer NexGen CR Knee System, K933785
- AMK© Fixed Stem Tibial Tray, K922620
Attune Knee Problems
Despite DePuy’s claim to the FDA that the Attune knee system was an improvement over existing knee replacement devices, Attune implant recipients began complaining about problems with their Attune knee systems. Problems reported by DePuy Attune knee implant recipients include:
- Pain in the joint especially when weight bearing
- Loosening of the joint
- Heat or warmth in the knee
- Joint instability
- Grinding in the knee joint
- Joint swelling
- Water on the knee (effusion)
- Dislocation of the device
- Debonding of the device’s cement
- Decreased range of motion (ROM)
- Attune knee joint out of alignment
- Nerve damage
- Fracture of knee system components
- Debris release from knee
- Fracture of femur or tibia
FDA Attune Component Recall 2015
The Attune device was subject to a Class II FDA recall in 2015. The Attune Knee Tibial Articulation Surface Instruments – tools used to implant the Attune knee implant – were recalled. One component of these, called a Balseal, contained a wire spring coil that could break off inside the patient without the doctor’s knowledge. That DePuy knee recall was terminated by the FDA on November 12, 2015.
Trust Our Massachusetts Attune Knee Implant Attorneys To Help
If you have experienced problems with an Attune knee replacement system, or with any other knee replacement, you may be eligible to file a personal injury claim for damages. You may be compensated for medical expenses from surgery to revise and replace your implant, and money damages for the pain, suffering, physical injuries, and any other losses, such as lost income, that you suffered as a result of your injuries.
Call Attorney Marilyn McGoldrick at 1-888-341-1405 or contact the Boston law firm of Thornton Law Firm LLP online or for a confidential, no-cost consultation with a specialist in Massachusetts drug and medical device litigation. If you have had problems with an Attune knee implant, you should seek legal advice as soon as possible, as courts apply strict time limits to all claims. Contact us today for a thorough, fair consideration of your legal claim.