(718) 428-4949

According to the FDA letter, the following medical products which are manufactured by Stryker at their plant could contain manufacturing defects due to poor manufacturing and quality control procedures:

 

• Trident PSL Acetabular Shells

• ReUnion Plasma Spray Humeral Stem

• Solar Plasma Purefix HA Shoulder Stems

• Duracon Total Knee Modular Femoral Component

• Global Modular Hip Stems

• Trident PSL HA Solid Black 52MM

• Trident Hemispherical Cluster 50MM

• Hip Implant components with ceramic bearing components

 

Stryker Orthopedics Corp, manufacturer of orthopedic devices, received a warning letter from the FDA about recurring problems with some of their Trident Hip Implant and other components. The substance of the warning letter dealt with certain manufacturing defects that could result in serious hip replacement problems which may require further surgery. Over the past years, Stryker has been receiving numerous complaints regarding certain orthopedic devices. Yet despite their knowledge of potential defects, Stryker continued to sell their product.

 

The alleged defects could cause any of the following problems:

 

• Clicking, grinding, or screeching

• Abnormal pain or limp

• Prosthesis failure or delamination

• Revision and replacement surgery

 

The FDA released the warning letter on their website. The FDA's investigation of a Stryker plant established 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 Trident Hip Implant parts and other hip replacement components between January 2005 and April 2007.

Reports from the FDA indicate that the defective hip replacement parts with ceramic bearing components could produce squeaking noises, resulting in pain and discomfort. These same 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.

 

Contact JEFFREY KIM, P.C. for a free consultation today at (718) 428-4949.