In a second stern warning, the FDA takes Stryker to task for failure to remedy defective, squeaky hip replacements.

In the latest round of correspondence regarding Stryker's defective hip implants, The U.S. Food and Drug Administration has said in a letter to the company there were customer complaints about squeaky ceramic hip joints, among other problems.

A copy of a warning letter sent to Stryker was posted on the FDA website on Tuesday, January 15, 2007.

It said infractions at the company's Mahwah, New Jersey, plant included failure to fix quality problems, including those related to its Trident hip-replacement systems. The 11-page letter was dated Nov. 28, 2007.

Among other issues, the FDA cited Stryker for "Failure to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems."

Inspectors from the FDA determined that Stryker "...has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries."

The letter then went on to give specific examples of the serious complaints received regarding the hip implants:

"For example, Complaint 64304, dated December 13, 2006, states that the patient felt grinding crunching and screeching in the right leg and felt unstable (pain when sitting) with your Alumina C-Taper Head. It was reported in the complaint that the [redacted] head was in "pieces". Complaint 71000, dated March 20,2007 reports that a patient went to the hospital because they felt that something was wrong and x-rays showed a broken cera (fractured or fragmented or cracked). The complaint reported that the device failed to function."

If you have experienced any problems with your Stryker Hip Implant, or if you are unsure of the model of your hip replacement, please complete the form below for a free case evaluation. We will be in touch shortly and look forward to addressing your concerns.
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