As the biggest manufacturer of joint replacement devices, Zimmer has faced a number of problems over the years that have led to recalls of its knee replacement systems in particular. Since merging with Biomet in 2015, the company’s troubles have continued, as additional recalls have been issued for various knee and other joint replacement medical devices.
Many of the Zimmer knee recalls have led to lawsuits and other legal actions against Zimmer Biomet.
Zimmer NexGen Recalls
Zimmer’s NexGen Knee Replacement Systems products are at the heart of the company’s recalls, with the NexGen Flex, particularly the tibial components, causing the most problems. The U.S. Food and Drug Administration (FDA) approved the NexGen Flex through a 510(k) submission, meaning that the device is simply a modification of a previous FDA-approved device and is just as safe and effective. As a result, the device did not undergo clinical trials before going to market.
Not long after receiving NexGen implants, some patients began to experience negative side effects. Many required revision surgery to replace their implants after as little as two years. Knee replacements typically last for up to 15 years.
Learning of these complications, Zimmer sent a device correction letter to surgeons addressing the implantation of their devices. The letter stated that the device may loosen if threaded incorrectly, and provided new instructions for successful implantation. The company did not allude to any issues with the device itself. In total, 114 patients filed Medical Device Reportings (MDRs) with the FDA complaining of loosening in the implant device that required revision surgery.
In September 2010, the FDA issued a Class 2 Recall for over 68,000 NexGen MIS Tibial Components. By that point, thousands of patients had received the implant.
Persona Trabecular Metal Tibial Plate Recall
On January 28, 2015, Zimmer initiated a voluntary recall of its Persona Trabecular Metal Tibial Plate, a component of the company’s Persona-branded knee replacement devices. According to the recall notice, Zimmer had received an increase in complaints that the tibial plates were coming loose and forming “radiolucent lines” – that is, linear spaces between the device and the joint cement holding it in place.
More than 11,600 knee replacement devices were affected by this recall. Zimmer instructed hospitals, orthopedic surgeons, and distributors to return the defective devices. It is unclear from the recall notice how many people may have already had the malfunctioning devices surgically implanted.
Other Zimmer Knee Device Recalls
Zimmer has issued a number of other recalls on parts related to its knee replacement devices. Many of these recalls were instituted before any of the knee replacement components could be surgically implanted into patients. However, there is still the risk that some of the components were not returned by the distributors, hospitals, or doctors to whom they were sent, and it is possible some of them may have been used in arthroplasty operations.
In 2010, Zimmer recalled the MIS Tibial Component after the company received reports about improperly locking screws and stems on the device. Over 100 people filed complaints to the FDA that the device was coming loose, which led to the need for knee revision surgery.
Sulzer Medica, a company acquired by Zimmer in 2003, paid $1 billion in 2002 to settle thousands of lawsuits filed by customers who received joint implants in their knees and hips. As it turned out, the manufacturing process for the company’s Natural Knee II Tibial Baseplate implant had left an oily substance on the device, which caused problems for patients up to a year later.
The table below provides a summary of other recalls that Zimmer has conducted over the last several years.
|Date||Product/Component Recalled||# Recalled|
|January 11, 2016||NexGen Knee system components||88,389|
|March 17, 2016||Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left||Unknown|
|December 3, 2015||NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat||384|
|October 2, 2015||Natural Knee II Revision Femoral Stem||352|
|April 30, 2015||PRI Femoral Impactor Block||1,689|
|March 10, 2015||Persona Anterior Referencing Sizer with Locking Boom||688|
|January 28, 2015||Persona Trabecular Metal Tibial Plate||11,658|
|November 24, 2014||Zimmer PERSONA Tibial Articular Surface Inserter||1,091|
|October 9, 2014||Persona Stemmed 5 Degree Cemented Tibia||138|
|October 7, 2014||Persona Tibial Articular Surface Inserter||618|
|August 7, 2014||Persona The Personalized Knee System – Constrained Tibial Articular Surface||77,737|
|July 30, 2014||Zimmer PERSONA Distal Valgus Alignment Guide||2,248|
|July 22, 2014||Knee Instrument Fixation Screws, Knee Stem Extensions & Impactor Sleeve||972,125|
|July 10, 2014||Natural-Knee System Patella Bushings||8,638|
|July 1, 2014||Persona The Personalized Knee System – Tibial General Instrument Tray||190|
|May 19, 2014||NexGen Complete Knee Solution||41,180|
|February 25, 2014||Gender Solutions Natural-Knee – Flex System||3,638|
|November 19, 2013||NexGen Complete Knee Solution – Patella Drill Guide, Articular Surface Provisional||3,027|
|October 31, 2013||NexGen Complete Knee Solutions Stemmed Tibial Component Precoat||128|
|August 30, 2013||Natural-Knee Flex – Femoral Component, Natural Knee II – Femoral Component, Zimmer Unicompartmental Knee – Femoral Component||80,007|
|June 10, 2013||Persona The Personalized Knee System – Tibial Articular Surface||70,986|
|June 7, 2013||NexGen Cruciate Retaining Complete Knee System – Micro Femurs, Articular Surface, Patellae||192,355|
|November 14, 2012||Persona Knee System – Natural Tibia, Tibial Sizing Plate, Tibial Drill, Tibial Drill Guide, and Tibial Broach||2,482|
|September 21, 2012||NexGen CompleteKnee Solution – Stemmed Nonaugmentable Tibial component||123|