Zimmer iAssist Knee Problems Results in FDA Warning Letter

Federal regulators have issued a warning letter over problems at a factory that makes Zimmer knee replacement system components, including the iAssist guidance system and other parts, indicating that there are numerous quality control issues that could lead to defective parts. 

The FDA sent a letter to Zimmer President and CEO David Dvorak in late May, following an inspection of its Montreal facility. According to the letter, the FDA considers the Zimmer iAssist Knee System, Zimmer PSI Shoulder System, Zimmer PSI Knee System and the Navitrack System to be adulterated products due to the deficiencies found at the facility.

The agency says it warned Zimmer previously about problems at the facility, however, the company’s responses to those problems were insufficient. Zimmer acknowledged receipt of the letter in a filing with the Securities and Exchange Commission (SEC).

In the letter, the FDA said Zimmer failed to adequately respond to complaints of problems with iAssist knee devices, including several complaints filed by doctors who reported that the iAssist broke while being implanted into patients.

Inspectors noted that eight out of 14 complaints filed in fiscal year 2015 failed to include the required Medical Device Reporting (MDR) determinations.

The FDA also noted that the company failed to establish adequate procedures to make sure equipment in the factory was properly calibrated, failed to conduct proper quality audits, failed to maintain proper MDR procedures, and failed to provide proper notification of several recalls and corrective actions throughout the last several years.

According to the FDA warning, until Zimmer properly addresses these issues, it will be limited in its ability to bring new devices to the market.

“The warning letter states that, until the violations have been corrected, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved,” Zimmer told the SEC. “The Company presently has no such applications before the FDA.”

Zimmer said it is working with the FDA to correct the problems at the factory and will continue to do so until the situation is resolved.