Reports of Zimmer total knee replacement failure have spurred the manufacturing company to initiate a voluntary recall of the device. Zimmer issued a recall of the Persona tibial plate after receiving more reports of complications than expected.

The Zimmer total knee replacement implant is directly implanted into the bone and directly attaches to the tibia. The implant has two pegs that are meant to directly grow into the bone.

The Zimmer total knee replacement devices are now causing the company to face intense public scrutiny. The U.S. Food and Drug Administration classified the company’s recall as a Class II recall on March 12, 2015, for certain Zimmer total knee replacement implants including: Zimmer Persona Trabecular Metal Tibial Plate/Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, and Polymer/Metal/Polymer devices.

The Zimmer knee replacement recall affected left and right knee implants, for sizes C through J.

Approximately 11,000 devices were affected by the recall, and many patients who opted for one of these Zimmer total knee implants had to undergo revision surgery to repair or replace the faulty knee implant.

According to the FDA, Zimmer voluntarily recalled these Zimmer total knee replacement implants after receiving reports of radiolucent lines and device loosening:

• Radiolucent Lines: These lines can be identified in x-ray images, which show gaps between the knee implant and the bone. This is a sign of “poor seating,” which occurs when the implant moves out of position.
• Loosening: Specifically, loosening is when the trabecular metal plate of the Zimmer total knee replacement implant comes loose from its original attachment site.

Many patients who received Zimmer total knee implants reported experiencing pain at the implant site and had to later undergo revision surgery due to the severity of the problems.

After Zimmer received notice of these injury reports, the company began investigating these complications. Based on injury reports and diagnostic imaging, it was concluded the Zimmer total knee replacement implants were loosening soon after implantation.

Zimmer has since sent the recall notice to healthcare facilities across the country, including surgeons and other medical professionals.

Critics say many of the Zimmer knee replacement problems allegedly stem from the fact the medical device was approved through the FDA’s 510(k) process. Medical devices that go through the FDA’s 510(k) process do not have to undergo intense pre-clinical trials or studies as long as the device is similar enough to another, already-released product.

Because the Zimmer Persona was approved through this program, many have alleged these Zimmer Persona total knee replacements were not properly evaluated for potential complications.

Some patients who opted for Zimmer total knee replacement products say they relied on the marketing materials provided by the company and were not aware of the severity of the potential complications.

Zimmer has since sent the recall notice to healthcare facilities across the country, including surgeons and other medical professionals.

Patients who opted for one of the Zimmer total knee replacement implants mentioned in the recall and issued before March 2015 may be eligible for legal action.