A total hip replacement system consists of 4 parts:
Stryker Corporation, a major medical device company, is the manufacturer of Tritanium Acetabular Cups, which were launched in 2008 and are used in two of its total hip replacement systems.
Since that time, reports began surfacing that showed the Tritanium Acetabular Cups are loosening prematurely--at times as quickly as three months after surgery. This in turn causes failure of the entire hip replacement, necessitating revision surgery. In general, hip replacements are expected to last up to 20 years or more.
In 2013, Stryker funded a study of their Tritanium cups which stated that there were no patient problems and the cups were performing well two to four years after surgery.
However, patient adverse event reports continued to be filed with the FDA. Because the Stryker Titanium cups are widely used, orthopedists became concerned. At NYU Langone Hospital in New York City, approximately 5,000 total hip replacements are performed each year; some 160 Tritanium cups were used in the same timeframe.
A 2017 study of the Stryker Tritanium Cup conducted by four orthopedic surgeons compared the results of 95 patients using the Tritanium cup to 100 patients who received a different Stryker cup. The results showed that over one-third of the Tritanium Cup recipients experienced key signs of loosening and lower Harris Hip Scores--a standard assessment of of hip surgery success.
Surgeon concern grew. In June 2018, Arthroplasty Today published a study conducted by prominent orthopedic surgeons at NYU Langone Orthopedic Hospital which showed that the Tritanium cups can come loose as early as 3 months after being implanted.
The team closely examined five patients that underwent hip replacement surgery using the Stryker Tritanium cups and who ultimately underwent revision surgery due to implant failure just months after surgery. Even though the surgeons elected to supplement the stability of the implant by also using screws, the Stryker cups did not adequately bond to the patients’ bones and became loose:
“The acetabular component was grossly loose with fibrous growth
around the periphery and no bony ingrowth.”
The Stryker Tritanium Acetabular Cup has not been recalled. However, NYU Langone Hospital has halted their use. In the 2018 study, the surgeons also recommended that the safety of the Stryker cups in total hip replacement surgeries should be examined.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.
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