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Metal-on-Metal Hips in the News

Metal-on-Metal Hips in the News

FDA to discuss risks and benefits of metal-on-metal hip replacements: Expert, patient recommendations being sought.

FDA's Orthopaedic Device Advisory Panel will meet in June 27-28, 2012 to seek expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip replacement and resurfacing, including failure rates, metal ion testing, complications, considerations for post-op follow-up, etc. The panel will also hear potential patient and practitioner recommendations on the use of MoM systems and the management of patients implanted with such devices.

Medical Device Recall Actions: Stryker MITCH Hip Implants Authorities in New Zealand (NZ) initiated a recall of the MITCH THR hip implant, following indications from registry data that suggest a higher-than-expected failure rate in the metal-on-metal device at 3-years post-op. Of 41 patients who received the implant, 3 required revision due to failure. The implant was manufactured by Finsbury Orthopaedics and distributed in NZ by Stryker.

REFERENCES

Press release, FDA.gov, March 29, 2012. www.fda.gov

Press release, Medsafe, New Zealand Medicines and Medical Devices Safety Authority, www.medsafe.govt.nz/hot/media/2012/RecallHipImplantDevice.asp, April 13, 2012.

Medical Device Recall Actions: Stryker MITCH Hip Implants, Medsafe, www.medsafe.govt.nz/hot/RecallActionNoticesNew/StrykerMitchHRModularHeadAndacetabularCup.asp, April 16, 2012.

4 COMMENTS

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cz

06/11/2012 06:10 PM
Smith & Nephew also issued a worldwide recall of the R3 liner
http://www.newsinferno.com/defective-medical-devices/smith-nephew-recalls-metal-on-metal-hip-implant-component/38292
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