Knee replacement devices have the potential to greatly benefit the lives of patients through increased mobility and diminished pain. However, such devices can also cause tremendous problems when they fail. GoldenbergLaw is currently handling cases involving failures of multiple knee replacement devices, specifically the DePuy Attune and Zimmer Persona systems.
Case Quick Facts
The Attune Knee Replacement System is manufactured by DePuy Synthes, a subsidiary of Johnson & Johnson. While the company has not yet recalled the Attune Knee Replacement System, this isn’t the first time DePuy has encountered problems with its knee replacement devices. Between 2002 and 2013, DePuy Synthes recalled 277 knee implant devices and components. Four of these were Class I recalls, indicating a “reasonable probability” that using the product will cause “serious adverse health consequences or death.” Then, in 2015, the corporation initiated a Class II recall of the Attune Articulation Surface component after finding a spring coil could break off and enter the surgical site without the surgeon’s knowledge. Now, reports are indicating frequent early loosening at the tibial base plate of the Attune likely due to a lack of bonding. Such loosening may not be evident on X-ray but nonetheless can cause immense pain and significant instability necessitating revision surgery.
The Persona Knee Replacement System is manufactured by Zimmer, Inc., the world’s largest manufacturer of knee implants, and consists of several parts that must work together to increase mobility and enhance quality of life in the manner patients are promised. The Trabecular Metal Tibial Plate is one such part. However, Zimmer has recalled nearly 12,000 of its Persona Knee Replacement Systems due to issues with the Trabecular Metal Tibial Plate. While the tibial plate is intended to be placed without the need for surgical cement, patient complaints indicate that the component is not functioning as intended. Instead, patients are developing radiolucent lines, discernible on X-rays, which are gaps between either the implant and the bone or between the implant components themselves. Such gaps can occur when an implant is improperly secured, and growth of these gaps may allow for the resultant space to fill with tissue or fluid and cause the implant itself to fail. Zimmer is also no stranger to defective products. In 2008, Zimmer recalled its Durom Cup hip replacement component after it was discovered that the implant sometimes failed to remain in place. In 2010, the company recalled 70,000 MIS Tibial components due to loosening issues. In 2014, 40,000 Zimmer NexGen Knee Implants were recalled for similar reasons.
Patients who have received the DePuy Attune Knee Replacement System are reporting premature device failure. Sometimes, such failure has been reported to have occurred within the first two months after surgery. Many of these reports are based on tibial baseplate loosening, which may result in serious pain along with potential bone loss, and muscle damage. In some cases, the loosening has led to dissociation where the bond between the bone and knee component has fallen apart completely. DePuy Attune Knee Replacement System failure often requires painful and invasive revision surgery, and some of the damage caused by these defective knee implants may be irreversible.
Similar injuries are being reported by patients with Persona implants. Once the parts begin to fail, patients will get serious pain that could come from bone loss, muscle damage, or infection. All in all, when these products fail, it causes a lot of pain for the patient, rather than helping them like the product is intended to.
DePuy and Zimmer.
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Studies and Reports
A study entitled Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface appeared in the June 2017 issue of the Journal of Knee Surgery. In the article, the authors presented data resulting from consideration of case reports involving patient presentation with pain at the initiation of weight bearing between one month and two years after implantation of the DePuy Attune Knee Replacement System.
Studies and Reports
After consideration of the data presented by the case reports of patients undergoing revision total knee arthroplasties for aseptic failure due to tibial component loosening at the implant-cement interface from three separate hospital databases, and especially in light of the typical presumption of early stability when considering cemented total knee arthroplasties, the authors concluded that implant-cement interface debonding must be considered in Attune patients presenting with unexplained pain.
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If you find yourself in need of a knee replacement recall lawyer, our Minneapolis team would be happy to look at your case. We have years of experience with cases in the medical field, which gives us the expertise to analyze your case and see what we can do for you.
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