Hip, Knee & Spine Implants

Hip implants

As of 2013, Stryker recalled over 200 models—a number slightly higher than recalls for manufacturer DePuy. People have suffered metal poisoning, broken bones, debilitating pain, and more as a result of the following implants:

DePuy (ASR XL Acetabular System)

The FDA’s class II recall of these hip systems was two months ahead of the company-initiated recall in 2010, following reports of toxicity and the release of metal debris into the body. Injuries from the DePuy ASR hip implant reportedly cost the company over $800 million.

Stryker (Rejuvenate Modular and ABG II Modular-Neck Hip Stems).

Stryker issued a voluntary recall of the Rejuvenate and ABG II hip systems just three years after the devices were put on the market. The recall came on the heels of an urgent field safety notice issued by the manufacturer, alerting doctors and hospitals to the risk of adverse local tissue reactions due to particle shedding in the devices.

Zimmer (Durom Acetabular Component, Zimmer M/L Taper with Kinectiv Technology).

The FDA issued a class II recall of Zimmer’s Durom Acetabular Component (known as the Durom Cup) in 2008 due to reports of premature failure, affecting over 19,000 implanted patients nationwide. In June 2015, the FDA issued a class I recall of the Zimmer M/L Taper with Kinectiv Technology when the agency discovered higher than acceptable levels of manufacturing residues left on the devices prior to implantation.

Wright/MicroPort Orthopedics (Profemur Z Hip Stem, Profemur Neck Varus/Valgus CoCR).

Wright Profemur hip defects included corrosion in the hip joint, fretting, and femoral neck fractures. The dangers prompted the FDA to issue a class I recall of the Profemur Neck Varus/Valgus CoCR, citing the devices probability to cause significant “adverse health consequences.”

Smith & Nephew (R3 Metal Liners of the R3 Acetabular System).

Smith & Nephew introduced its R3 Acetabular System to the U.S. market in 2009, and over 3,000 Americans were implanted with the device and its optional metal liner. While the metal component was marketed as making the device more durable, Smith & Nephew later admitted that the lining suffered from performance issues. The company initiated its own recall of the devices in 2012 due to growing reports of sudden loosening and dislocation of the implant.

Knee implants

The majority (619) came from the three largest orthopaedic manufacturers in world at the time: Zimmer, DePuy and Stryker.
The following knee replacement products have also been recalled:

Zimmer knee implant recalls:

• The Zimmer NexGen LPS-Flex GSF Femoral component
• NexGen MIS Tibial components
• NexGen TM Tibial Trays
• NexGen LPS-Flex GSF Femoral component
• NexGen MIS Modular Tibial Plates and Keels

Stryker

• Duracon Total Knee
• Unicompartmental Knee System
• Scorpio PS and CR components

Biomet

• Vanguard CR

Smith & Nephew

• Journey Uni Tibial Baseplate
• Oxinium Genesis II and Profix II

Spine implants

Defective spine implants can prove deadly, potentially resulting in paralysis, serious injury or even death. Recalled spine implants include:

• Stryker Spine OASYS Midline Occiput Plate System
• Genesys Spine Binary Anterior Cervical Plate System
• DePuy Spine Skyline Anterior Cervial Plate System
• Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System
• uNion Cervical Plate System
• Captiva Spine SmartLOX Cervical Plate System
• ATLANTIS(R) Anterior Cervical Plate System