Zimmer Suspends Sales Of Hip Implant
July 28, 2016 at 4:25 p.m.
By Jen [email protected]
Zimmer Holdings Inc., Warsaw, recently announced that it has voluntarily suspended the distribution of the Durom® Acetabular Component, or Durom® Cup, which is used in total hip replacement procedures.[[In-content Ad]]The company plans to update the labeling on the implant and give doctors more detailed instructions and training regarding the surgical technique used to install the device.
Some patients have experienced loosening of the Durom® Cup, which is mainly used with Zimmer's Metasul® Metal-On-Metal Tribological Solution LDH (Large Diameter Heads). The cup is constructed of cobalt chromium and has a pure titanium plasma-sprayed coating to affix it to the head implant.
The implant was launched in Europe in 2003 and in the United States in 2006.
Once concerns about the implant were directed to Zimmer, the company reviewed clinical data and re-examined the processes used to implant the device.
According to information released by Zimmer, "a total of 12 clinical sites that were among those with the highest patient volume for Durom® Cup implants in both the U.S. and Europe were visited so that the largest number of patient cases could be reviewed in the shortest amount of time. Eight clinical sites were reviewed in the U.S. and four in Europe. In the U.S., Zimmer reviewed more than 1,300 patients - approximately 10 percent of all U.S. procedures involving the Durom® Cup to date. ... More than 3,100 cases were examined overall."
"We continue to believe, based on the results of our comprehensive investigation, that the Durom® Cup is a safe and effective device when used as intended," Cheryl Blanchard, senior vice president of research and development and chief scientific officer at Zimmer, said in a press release. "With appropriate training support to surgeons, we are confident of achieving patient outcomes in the U.S. that are as consistent as what we have seen historically in Europe."
The company plans to update the training procedures for the implantation of the device and provide more specific instructions to surgeons about performing the procedure.
According to Brad Bishop, media contact at Zimmer, the surgical technique for the implantation of the device has not changed. The company plans to re-label the the implant and provided more detailed surgical instructions. Also, surgeons will undergo specific training to learn the procedure for implantation of the Durom® Cup.
"The training will be put on by Zimmer, and (surgeons will be taught) how to properly use the (Durom® Cup)," said Bishop.
The company currently is in the process of revising the training techniques, and there is no timetable for when the device may be returned to the market.
According to a press release from the company, "Zimmer has found no evidence of a defect in the materials, manufacture or design of the implant. The company has identified that surgeons who regularly achieve the desired outcome with the Durom® Cup consistently execute crucial technique steps and place the cup in a specific manner. Following its review, Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical results in the the U.S."
Zimmer recommends that patients who experience pain more than three months after their procedure contact their doctor. Patients wanting more information should call Zimmer at 888-946-5633.
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Zimmer Holdings Inc., Warsaw, recently announced that it has voluntarily suspended the distribution of the Durom® Acetabular Component, or Durom® Cup, which is used in total hip replacement procedures.[[In-content Ad]]The company plans to update the labeling on the implant and give doctors more detailed instructions and training regarding the surgical technique used to install the device.
Some patients have experienced loosening of the Durom® Cup, which is mainly used with Zimmer's Metasul® Metal-On-Metal Tribological Solution LDH (Large Diameter Heads). The cup is constructed of cobalt chromium and has a pure titanium plasma-sprayed coating to affix it to the head implant.
The implant was launched in Europe in 2003 and in the United States in 2006.
Once concerns about the implant were directed to Zimmer, the company reviewed clinical data and re-examined the processes used to implant the device.
According to information released by Zimmer, "a total of 12 clinical sites that were among those with the highest patient volume for Durom® Cup implants in both the U.S. and Europe were visited so that the largest number of patient cases could be reviewed in the shortest amount of time. Eight clinical sites were reviewed in the U.S. and four in Europe. In the U.S., Zimmer reviewed more than 1,300 patients - approximately 10 percent of all U.S. procedures involving the Durom® Cup to date. ... More than 3,100 cases were examined overall."
"We continue to believe, based on the results of our comprehensive investigation, that the Durom® Cup is a safe and effective device when used as intended," Cheryl Blanchard, senior vice president of research and development and chief scientific officer at Zimmer, said in a press release. "With appropriate training support to surgeons, we are confident of achieving patient outcomes in the U.S. that are as consistent as what we have seen historically in Europe."
The company plans to update the training procedures for the implantation of the device and provide more specific instructions to surgeons about performing the procedure.
According to Brad Bishop, media contact at Zimmer, the surgical technique for the implantation of the device has not changed. The company plans to re-label the the implant and provided more detailed surgical instructions. Also, surgeons will undergo specific training to learn the procedure for implantation of the Durom® Cup.
"The training will be put on by Zimmer, and (surgeons will be taught) how to properly use the (Durom® Cup)," said Bishop.
The company currently is in the process of revising the training techniques, and there is no timetable for when the device may be returned to the market.
According to a press release from the company, "Zimmer has found no evidence of a defect in the materials, manufacture or design of the implant. The company has identified that surgeons who regularly achieve the desired outcome with the Durom® Cup consistently execute crucial technique steps and place the cup in a specific manner. Following its review, Zimmer has determined that revised surgical technique instructions and a surgical training program are required to more consistently achieve desired clinical results in the the U.S."
Zimmer recommends that patients who experience pain more than three months after their procedure contact their doctor. Patients wanting more information should call Zimmer at 888-946-5633.
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