Medical device maker Stryker said last week that it will voluntarily recall the hip implant surgery products Trident PSL and Hemispherical Acetabular Cups.
This recall comes on the heels of a warning from the FDA to fix a host of long-standing problems, primarily the failure to function and poor fixation with its hip implant components and in its manufacturing of hip replacement parts. These defective Stryker products have led to numerous complaints and forced some artificial hip implant patients to have additional surgeries. In fact, the FDA told Stryker that it was aware that Stryker had received complaints about the improper fitting of hip implants that caused bone fractures in some patients three years ago.
The following Stryker products were named in the FDA investigation for containing manufacturing defects that are potentially harmful to hip and joint replacement patients:
• Hip Implants with ceramic components
• Solar Plasma Purefix HA Shoulder Stems
• Trident PSL Acetabular Shells
• Duracon Total Knee Modular Femoral Component
• Global Modular Hip Stems
• Trident PSL HA Solid Black 52 MM
• ReUnion Plasma Spray Humeral Stem
• Trident Hemispherical Cluster 50 MM
Almost all products liability cases against medical device manufacturers are design defect cases. In these Stryker Trident hip implant defects cases, the negligence appears to be in the manufacturing process rather than a problem associated with the way the Stryker products were originally designed.
It appears hard to argue that Stryker, a Michigan based company that before this news came out was having a great run of profitability, has done something wrong here. In the FDA’s letter stemming from its inspection of Stryker’s Mahwah, New Jersey manufacturing plant, complaints were that Stryker failed to correct their manufacturing procedures that led to complaints about their hip replacement products in the first place. It says one thing about Stryker when the FDA notes manufacturing deficiencies in the first place. It says quite another thing about Stryker when they fail to fix the defects that have been previously brought to their attention.
A lot of lawyers will be looking at these cases very closely to see whether there are enough injuries for a class action lawsuit against Stryker for these defective hip replacement products. Whether class litigation will be viable will depend on the number of reported injuries and the severity of those injuries.
Our lawyers are currently reviewing cases. If you want to discuss your case with one of our Stryker defective hip replacement lawyers, call us for a free consultation at 800-553-8082 or click here for a free Internet consultation.