Stryker Corp., which manufactures hip replacement parts, received a warning letter from the FDA about recurring problems with some of their Trident Hip Implant and other components. Manufacturing defects could result in pain, bone fractures or other serious hip replacement problems which may require further surgery. Despite reports received by the company over the past three years, they have not adequately corrected manufacturing problems and have continued to sell hip replacement parts which may fail.
>>FDA Warning Letter: Striker Trident Hip Implant Manufacturing Defects
The FDA released the warning letter on their website this week, but it was sent to the company on November 28, 2007. The FDA’s investigation of a Stryker plant in New Jersey found that manufacturing problems and poor quality control have resulted in potentially defective hip implant and hip replacement parts being sold nationwide. According to the FDA letter, the company received complaints about their Tident Hip Implant parts and other hip replacement components between January 2005 and April 2007, yet they have not adequately addressed the problems
The defective hip replacement parts with ceramic bearing components could produce squeaking noises, resulting in pain and discomfort. Reports also indicate that some of the Trident Hemispherical and Trident PSL cups have failed to function properly and hip implant components have been found to have poor fixation, which could result in serious bone fractures. In some cases, individuals who received the hip replacements required a second surgery due to implant failures.
According to the FDA letter, the following medical products which are manufactured by Stryker at their New Jersey plant could contain manufacturing defects due to the poor procedures in place to prevent nonconforming products and other quality problems:
- Trident PSL Acetabular Shells
- ReUnion Plasma Spray Humeral Stem
- Solar Plasma Purefix HA Shoulder Stems
- Duracon Toatal Knee Modular Femoral Component
- Global Modular Hip Stems
- Trident PSL HA Solid Black 52 MM
- Trident Hemispherical Cluster 50 MM
- Hip Implant components with ceramic bearing components
STRYKER TRIDENT HIP IMPLANT LAWSUITS
The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential hip replacement lawsuits for individuals who suffered an injury as a result of defective Stryker Trident Hip Implant components. Despite knowledge of potential defects in their product, they failed to take actions which could have prevented serious and permanent injuries for some of their customers. If you, a friend or family member have suffered a serious injury, fracture or additional surgery as a result of a hip replacement problems, request a free consultation.