DePuy Receives PMA for TRUMATCH

What with their focus on precision, the engineers at DePuy Orthopaedics, Inc. must be especially thrilled…the company’s TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System has received Premarket (PMA) Supplement Approval from the FDA. Already in use in 17 countries, TRUMATCH Solutions for use with DePuy’s SIGMA Fixed Bearing Knee System was previously cleared in August 2011. And this made DePuy the only orthopedic company to have personalized instrumentation for use with both rotating platform and fixed bearing knees.

“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” said Andrew Ekdahl, President, DePuy Orthopaedics, in the February 15, 2012 news release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room.”

As indicated by the company, the TRUMATCH is the first system to utilize CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient. Also, TRUMATCH Solutions uses CT scans, rather than MRIs, for improved bone imaging, less scanning time and lower costs. DePuy states that procedures done with TRUMATCH Solutions also require less instrumentation and eliminate up to nine surgical steps compared to total knee replacement performed without TRUMATCH Solutions.

DePuy receives FDA premarket supplemental approval for TRUMATCH system

DePuy Orthopaedics Inc. has received premarket supplement approval from the FDA for use of TRUMATCH Personalized Solutions with DePuy’s SIGMA RP Knee System. The system was previously cleared in Aug. 2011 for the SIGMA Fixed-Bearing Knee System, making DePuy the only orthopedic company to offer personalized instrumentation for use with both rotating platform and fixed bearing knee prostheses, according to a company release.

“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the SIGMA RP Knee, with TRUMATCH Personalized Solutions,” Andrew Ekdahl, president of DePuy Orthopaedics, stated in the release. “This approval means patients can now benefit from precise implant positioning, enabled by TRUMATCH Solutions, and the proven performance of both the SIGMA RP and Fixed Bearing Knee Systems, while increasing efficiency in the operating room,” he stated.

TRUMATCH Personalized Solutions, according to the release, is a surgical instrumentation and computer software system designed to aid both knee implant positioning and procedure efficiency.

Tennessee Hip Replacement Patient Files Suit Against DePuy For Alleged Debilitating Injuries

Kathryn E. Barnett of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Paul McCurley of Chattanooga, Tennessee, has filed a lawsuit against DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson, Inc., for the injuries he suffered after his DePuy Pinnacle metal on metal hip implant failed.

The lawsuit charges that DePuy knew that the Pinnacle metal on metal hip generated unusual and dangerous levels of metal debris accumulation in many patients and presented abnormally high risks of early failure. Despite notice of these alleged problems and defects, DePuy continued to promote and sell the Pinnacle metal on metal hip, and has not recalled the product.

On January 17, 2006, McCurley underwent a right total hip replacement procedure usi

DePuy suspends distribution of custom devices following FDA warning

Posted on : 23 January 2012

Johnson & Johnson subsidiary Depuy Orthopaedics has decided to stop selling all custom devices following an FDA letter warning. The FDA requires DePuy to file new new PMA or 510(k) applications for several components including:

1. PFC Sigma Knee System with titanium components and Global Advantage Shoulder System with titanium heads;

2. PFC Sigma Knee System components, sizes 2.5, 7, and 8;

3. PFC Sigma Knee System, 30 mm – 40 mm thick inserts;

Tennessee Hip Replacement Patient Files Suit Against DePuy For Alleged Debilitating Injuries

Lawsuit Charges Pinnacle Metal on Metal Hip Implant Manufactured by DePuy is Defective

Kathryn E. Barnett of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Paul McCurley of Chattanooga, Tennessee, has filed a lawsuit against DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson, Inc., for the injuries he suffered after his DePuy Pinnacle metal on metal hip implant failed.

“In one study, hip replacement patients who have undergone a revision surgery were almost four times more likely to suffer from hip dislocation than those who have not.”


The lawsuit charges that DePuy knew that the Pinnacle metal on metal hip generated unusual and dangerous levels of metal debris accumulation in many patients and presented abnormally high risks of early failure. Despite notice of these alleged problems and defects, DePuy continued to promote and sell the Pinnacle metal on metal hip, and has not recalled the product.