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Zimmer is a pioneer in providing hip/knee replacement solution that reduces pain, restores mobility and improves the quality of life of the patients. The products like femoral (neck and stem) components, acetabular (cup) components and revision surgery systems are manufactured by Zimmer.
The technique of Metasul Metal-on-Metal articulation and Trabecular Metal technology is used in manufacturing these implants which are capable of providing good level of friction resulting in faster joint stabilization. But there was a major issue encountered because of the metal grounding on metal, as it lead to toxic metal shards been released in patient's surrounding tissues and bone. Gradually, these toxins have resulted in causing inflammation, infection, decay of soft tissue and bone, severe pain and many other adverse reactions, requiring surgery to remove and replace the implant.
FDA approved Durom Acetabular Component (commonly known as Durom Cup) in 2006 for use in total hip replacement to address durability and range of motion of the joint. The young patients with more physical lifestyle were targeted and implanted, and it was observed it lead to serious injuries within short time.
Major complications of Zimmer knee/hip include:
- Premature loosening
- Severe pain
- Inflammation and swelling
- Limited mobility
- Bone, joint, muscle or neurological damage
- Shedding of metal debris into the bloodstream
- Metallosis (the buildup of metal ions in the body)
- Component corrosion
- Popping, crunching or other noises from the hip caused by movement
- Fractures of one or more components
Zimmer Holding was targeted by FDA as several reports of adverse events and complications related to the NexGen Flex Knee as well as Durom Cup were noted. In September and December 2010, many implants were recalled. In March 2015, there was a recall for Persona Trabecular Metal Tibial Plate by FDA. Approximately above 1,000 Zimmer NexGen cases have been noted.
Many federal cases regarding the Zimmer Durom Cup were transferred to the U.S. District Court for the District of New Jersey on June 9, 2010. Along with Zimmer (which recently purchased Biomet), other companies such as DePuy, Stryker, Wright Medical, etc. are also involved.
Litigation has been filed with regard to the following NexGen models:
- NexGen Complete Knee Solution (LPS-Flex)
- NexGen Complete Knee Solution Gender Solutions Female LPS-Flex (GSF LPS-Flex)
- NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)
- NexGen Complete Knee Solution CR-Flex Gender Solutions Female CR-Flex (GSF-Flex)
- All NexGen MIS Total Knee Procedure Stemmed Tibial Components
- Zimmer Durom Cup
Evidence to be looked for in potential cases
- Indication of Zimmer knee/hip usage in Medical Records
- Detailed Operative reports
- Implant Sticker and relevant details like Product Code, Manufacturer, Lot number
- Follow up complications and their treatment after Zimmer knee/hip implant insertion
Medical Record Review and claim validation of Zimmer knee/hip case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.