Designed by DePuy Synthes, a subsidiary of Johnson & Johnson, ATTUNE Knee was intended to improve the range of motion, stability and quality of life in patients who underwent knee replacement surgery. It promised a quicker recovery and more natural movement. The product was introduced to the market in 2011 and the company has stated it was one of the largest R&D projects in DePuy Synthes’ history. Despite all of their research, the company filed dozens of reports with the FDA documenting premature failures of the ATTUNE Knee system.
Unfortunately, ATTUNE Knee became associated with numerous complaints from its patients:
At least one study performed on ATTUNE Knee found “unusually high” failure rate which may stem from failing to bond components to the tibia, one of the bones in the lower leg commonly referred to as the “shinbone.”
In 2015, DePuy recalled nearly 14,000 ATTUNE Knee surgical tools. To date, there have been no recalls of ATTUNE Knee implants.
The FDA’s database shows at least six other DePuy knee recalls since 2013. Below is a list of recalls:
December 2017: 7,500 SIGMA HP PFJ Cemented Trochlear Implants recalled for elevated revision rates. READ MORE.
January 2016: 351 SIGMA HP MBT Non-Keel Punch Knee Instruments recalled for design flaw that could cause a delay in surgery. READ MORE.
September 2015: 7,488 Specialist 2 Intramedullary (SP2 IM) Rob recalled for instrument fracturing during surgery and leaving parts of the rods in patients. READ MORE.
June 2015: 13,964 Attune Knee Tibial Articulation Surface Instruments recalled because product could come off during surgery, leaving a part in device in patient. READ MORE.
March 2015: 28,732 LCS Complete RPS Inserts recalled on reports of higher revision surgery rates in Australia. READ MORE.
November 2014: 7,944 Attune Intuition Impaction Handle recalled on reports of fractures, potentially leavings parts in the patient. READ MORE.
November 2014: 4,555 Attune Intuition Impactors recalled because product could fracture, potentially leaving parts in the patient. READ MORE.
February 2014: 129 S-ROM Noiles Rotating Hinges recalled because defective packaging could compromise sterility. READ MORE.
Key reasons for knee replacement recalls:
Faulty Design - Components prone to fracture. Tools had flawed designs.
Improper Fit - Damage when forcing components into place.
Loosening - Revision surgery needed due to loosening knee replacement.
Early wear - Parts wearing out sooner than expected