In February of 2003, Stryker received approval from the FDA to market its Trident Hip Replacement system, and its products were soon being used in numerous hip replacement surgeries across the country. Soon thereafter the company began to receive complaints about its hip replacements and failed to take any action to accommodate those who had been affected by faulty equipment or to recall and improve its equipment. Stryker’s unwillingness to take early action has led to legal pressure in the form of litigation and scrutiny from the FDA, which has pressured the company to recall all of the products in its Trident line in 2008.
In July of this year, the company announced another recall— this time of its modular neck stems (specifically: Rejuvenate Modular and ABG II Modular-Neck Hip Stems), which has led many to wonder if the company is ever going to learn from its errors.
Hip replacement surgery is typically reserved for patients who have severe arthritis, have experienced multiple fractures to their hips or who have osteoarthritis— a condition that causes the cartilage in the joint to wear away until the bones in the joint make contact and grind against each other. The most common hip replacement option is to insert a socket into the joint and to attach a ball to the socket in order to mimic the natural movement of the joint as accurately as possible. Most hip replacements are made of metal or plastic components and the Trident line went against the grain by using ceramic, a material that poses concerns over how sterile the hip replacement will be and whether it could shatter and injure the patient.
Complaints Leading to Recall of Stryker’s Trident Hip Replacement
Many of the ceramic implants made by Stryker made popping and squeaking noises that not only caused embarrassment, but also signaled that there may have been more serious concerns with the hip replacements. Doctors began to express concerns primarily about whether the material would shatter and what impact the resulting shards would have on the patients’ joints but also took the popping and squeaking as signs that the hip replacement could cause discomfort or wear down more quickly than Stryker indicated.
After receiving repeated complaints between 2005 and 2007, Stryker had not taken any action to address any of the concerns that patients and doctors had about its products. The FDA acted in March of 2007 with a written warning to the company. After Stryker ignored the first warning, a second was issued in November of the same year. It took repeated hounding and numerous lawsuits before Stryker announced a recall of its Trident hip replacement system components in January of 2008.
Problems On The Horizon: Pending Litigation and New Recall
Many of the lawsuits filed against Stryker over its Trident system still remain unresolved and the announcement of another recall of the companies hip replacement devices suggests that there will be another wave of litigation as more patients file lawsuits over defective Stryker products. Stryker’s products are manufactured in New Jersey and because the courts in Michigan— where Stryker is headquartered— is considered to be less favorable venue from a litigation strategy, many of the cases have been filed in State Court in New Jersey. Some patients have elected to file lawsuits in their states of residence as well.
Taking into consideration what was required in order to push Stryker to recall its Trident system; when it announced the recall of its Rejuvenate and ABG II Modular-Neck Stems this July due to “a potential for fretting and corrosion at the modular-neck junction which may lead to adverse local tissue reactions,” one has to wonder how many more patients have suffered because of defective hip replacements. Even more, no one envies the position that Stryker is about to find itself as a new wave of litigation looms on the horizon and the company seeks a settlement for sins of the past.