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FDA, Food & Drug Administration, food and drug administration fda, Hip Replacement, Medical device, Nephew, NephewSmith, R3 Acetabular System, Smith
Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney.
The Smith & Nephew R3 Hip Implant Liner Recall Lawsuit
Smith and Nephew PLC has recalled the metal liner used in its R3 Acetabular System after due to poor performance and reports of injury and complications such as infections, fractures and dislocations. Nearly 8000 patients have been implanted with a Smith & Nephew R3 hip implant. The majority have been used in stemmed total hip replacement.
The company has chosen to withdraw the optional metal liner component within the R3 Acetabular System as a precautionary measure after reviewing recent data collected showing the liner not performing as anticipated. Smith & Nephew indicated the metal liner component within the R3 Acetabular System is “not performing as well as we would like.”
The Smith & Nephew R3 Acetabular Primary Cup System Hip Implant
Smith & Nephew launched the R3 Acetabular Hip System in March of 2008. The medical device is a multi-bearing acetabular cup system used in total hip replacement procedures.
The R3 Acetabular Cup was manufactured and designed for multiple bearing options, and uses a STIKTITE porous liner to aid in bonding with the bone.
There are three different types of liners used in the R3 Acetabular Hip
- R3 TM Ceramic Acetabular Liner (Ceramic Liner)
- R3 TM Constrained Liner (Acetabular Liner)
- Biolox Forte Liners (Ceramic Liner)
The R3 Forte Ceramic Liners were recalled due to an alleged manufacturing defect. A small number of the liners had titanium rings that were pressed with a higher force than manufacturing specifications allowed causing the liners to weaken. In March 2011, the U.S. Food and Drug Administration (FDA) announced a recall for the Ceramic liners.
The R3 TM Constrained Liners were recalled after Smith & Nephew received reports from surgeons claiming that the femoral head separated away from the liner during the operation.
Patients implanted with a Smith & Nephew hip implant with a recalled R3 liner may need revision surgery to correct the problem.
Free Smith & Nephew Hip Liner Recall Lawsuit Case Evaluation:
If you or a loved one have suffered or been injured from a defective Smith & Nephew Metal on Metal Hip Implant or needed a hip implant revision surgery you may be entitled to compensation. Contact the Smith & Nephew hip Implant attorneys of Ennis & Ennis today for a free confidential case evaluation by calling toll-free nationwide 1 800 856 6405 or complete the free case evaluation form on this page.
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- Stryker Hip Replacement Recall Second This Year (prweb.com)
Does Smith & Nephew not hear the cries from victims of their BHR hip device ?
It seems the BHR isn’t doing such a great job.
Metal on metal hips are proving to be more hazordous to our health each day as the complaints mount up.
It is bad enough the FDA needs more studies, more this and more that and still after more than enough time they are not pulling these devices off the shelf.
After all who will explain the sudden drop in net income to the investors and what about us POOR LAB RATS that have had their lives devastated for ever ???
Capitol Hill is so concerned ( or influenced ) about pulling these devices off the market, it could mean a loss of jobs via the medical device manufacturers and tax dollars to our Government, but it could preserve the quality of lives of 1000′s of innocent people.
Read the minutes on the September 8, 2005 FDA meeting held in Washington, DC, that panel approved a metal on metal hip resurfacing device, pma (post marketing approval) at that meeting. There were just as many if not more concerns and unanswered questions raised at the meeting than today 2012, but the FDA passed the device for marketing in the USA.
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