Stryker Working to Resolve FDA Warning Letters

Stryker Corp. indicates that it has resolved one of four FDA warning letters issued in recent years over concerns about manufacturing problems and other quality control issues, satisfying concerns the agency had over its Massachusetts Biotech plant.

According to Stryker, all of the FDA’s concerns outlined in an April 2008 warning letter have been addressed. The letter warned that FDA inspectors determined Stryker did not get the proper FDA approval for the OP-1 implant, a bone growth material meant for use as an alternative to autografting. The agency also expressed concerns over Institutional Review Board (IRB) documents that appeared to have been falsified by Stryker sales personnel.

The company has received a number of warning letters from FDA over its medical devices in recent, and there are still three outstanding letters with issues the company is working to address.

The most recent letter, which was issued in May 2009, involved a Stryker custom cranial implant kit that has since been discontinued. The FDA said Stryker did not get proper approval for that device as well before releasing it to the market. In December 2008, Stryker issued a recall for the cranial implant kits, saying that the devices may not be sterile and could pose a risk of serious infections for individuals who received the implants to correct traumas or defects in the jaw and face or cranium and face.

Stryker also received two other warning letters in 2007 involving manufacturing problems at their plants in New Jersey and Ireland, where certain hip replacement devices are manufactured. In March 2007, an FDA warning letter was issued about quality levels at the Ireland plant, indicating that the company failed to fix problematic products and known risks. In November 2007, another FDA warning letter was issued about problems at a New Jersey plant, including the presence of staph infection causing bacteria and other quality control issues.

The FDA has also indicated that Stryker failed to adequately address reports of Trident hip replacement problems received by the company between 2005 and 2007. The issues included reports of patients who continued to experience discomfort and pain after hip replacement surgery, improper wear of the hip implants and squeaking Trident hips.

After an internal company investigation discovered that certain implant components manufactured at their Ireland plant deviated from the manufacturing specifications, a Stryker Trident recall was issued in January 2008 for the certain Trident Acetabular Cup Systems and Trident Hemispherical Cup Systems.

The company currently faces a number of Stryker Trident hip lawsuits involving claims that the components have loosened or resulted in squeaky hips, which not only causes embarrassment, but can reduce an individuals ability to participate in activities that they otherwise would and may result in additional hip surgery.

Last year Stryker indicated that they will spend more than $150 million over the next three years on quality control systems designed to address manufacturing problems. They are also devoting resources to monitor quality data and adverse event reports to help them identify production problems earlier.