FDA Warning Letter Over Problems with Stryker Trident Hip Implants Resolved

Stryker Corp. announced this week that it has been declared in compliance with FDA manufacturing standards after more than two years of concerns over operations at one of its medical device plants that manufactured the Stryker Trident hip implant. 

In a press release issued on Tuesday, the company said it had been informed by FDA that it satisfied issues raised in a 2007 warning letter over quality issues in its reconstructive implant factory in Mahwah, New Jersey. However, the announcement does not mention two remaining outstanding warnings from FDA over manufacturing in Ireland or how the company sterilized its discontinued cranial implant kits.

The warning letter for the New Jersey facility was issued on November 28, 2007, when FDA inspectors found that quality control failures contributed to problems with Stryker Trident hip implants, including the presence of staph infections causing bacteria and other quality control issues. 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. The warning letter was one of several the company has been battling to resolve.

According to a 2008 study in the Journal of Arthroplasty, about 7% of individuals who received ceramic hip implants from 2003 to 2005 developed squeaking hips, compared with no reports of squeaking among the control group who received metal and plastic hip parts. A number of Stryker Trident hip lawsuits have been filed by individuals who experienced the squeaking hip implants or other problems. The lawsuits allege that Stryker negligently designed the hip implant and failed to adequately warn about the risk that individuals may end up with a hip that squeaks. In many cases, plaintiffs have required additional hip surgery to replace components.

The most recent FDA warning letter sent to Stryker, which was issued in May 2009, involved a 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.

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 October, Stryker announced that it had resolved a fourth warning issued by FDA inspectors who said that the company 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.