PORT WASHINGTON, N.Y., Oct. 3, 2017 /PRNewswire/ -- Parker Waichman LLP, a national law firm that has long fought to
The research was recently published in the Journal of Knee Surgery and reviewed numerous U.S. Food and Drug Administration (FDA) reports received on its Manufacturer and User Facility Device Experience (MAUDE) database concerning the Attune knee. A search of the MAUDE system revealed a total of 232 reports related to the device, according to Mass Device, citing the September 2017 issue of the Journal of Knee Surgery. (https://www.thieme-connect.com/DOI/DOI?10.1055/s-0037-1603756)
The researchers said they reviewed clinical, radiographic, and intra-operative findings for patients implanted with the Attune system and required revision surgery, which involves removing and replacing the allegedly defective device. The researchers reviewed three hospital databases for patients diagnosed with tibial loosening at the implant-cement interface, and found 15 cases. "Patients presented with pain on weight bearing, effusion, and decreased range of motion (ROM) within two years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in two of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing and rotating platform bearing designs," study authors wrote. "Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface," they added, according to Mass Device.
Researchers noted 21 reports made to MAUDE of tibial loosening at the so-called "implant-cement interface" in just the past two months, with "numerous other tibial failures" reported without the reports specifying the mechanism for failure. "We believe that this complication is underreported due to failure of radiographs to assess loosening. In addition, MAUDE database reporting is not consistent and competing companies cannot provide data on the revised components. In patients who have negative workup for a painful joint, one must consider the diagnosis of debonding," study authors wrote, Mass Device reported.
At least one lawsuit has been filed alleging premature failure of the Attune device, citing the published research in the Journal of Knee Surgery. "We expect to see increasing lawsuits given the seriousness of the injuries and under-reporting of these injuries associated with the DePuy Attune Knee," said Keith Gitman, Managing Attorney at Parker Waichman.
Filing a DePuy Synthes Attune Knee Replacement System Lawsuit
Parker Waichman has long represented clients in medical device injury lawsuits. If you or someone you know is interested in filing a DePuy Synthes Attune Knee Replacement System lawsuit, please contact Parker Waichman LLP at the firm's website at yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
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SOURCE Parker Waichman LLP
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