{"id":800,"date":"2017-07-10T15:13:30","date_gmt":"2017-07-10T14:13:30","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=800"},"modified":"2017-07-10T15:15:09","modified_gmt":"2017-07-10T14:15:09","slug":"depuy-synthes-elbow-implants-mhra-recall","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/depuy-synthes-elbow-implants-mhra-recall","title":{"rendered":"DePuy Synthes elbow implants recalled by the MHRA"},"content":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for <em>radial head elbow artificial replacements<\/em> amidst concerns over post-operative loosening of the device.<\/p>\n<p>Manufactured by DePuy company <em>Synthes<\/em>, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved Radial Stem implants are both affected by the recall. The recall follows on from a Field Safety Notice (FSN) issued back in December 2016 by the company&#8217;s Senior Quality Assurance Manager, Anne Brisson.<br \/>\n<!--more--><br \/>\nThe FSN notified relevant health providers of the issues and the imminent recall. Instructions were provided to stop using the implants until Synthes can narrow down the cause of the loosening.<\/p>\n<p>As the medical device manufacturer has been unable to identify the cause of the loosening, they&#8217;ve had no choice but to recall <strong><em>all<\/em><\/strong> the &#8220;DePuy Synthes Radial Head Prosthesis Stem from the global market&#8221;.<\/p>\n<h2>Artificial elbow joints<\/h2>\n<p>The prostheses acts as an artificial joint in the elbow where soft cartilage in the elbow joint has been worn away or damaged by a bad fracture. The devices look like large screws with a smooth concave surface to allow the joining bone to move free of friction.<\/p>\n<p>The stem of the devices are inserted inside the radius bone with a textured surface that encourages bone growth for the natural bone to envelope the stem. Unfortunately, for reasons still unknown to the company, the devices can become loose and cause pain, and problems with mobility, for the patient.<\/p>\n<h2>All patients to be notified<\/h2>\n<p>All patients who have had the implants inserted are to be notified of the recall, and healthcare providers are advised to keep an eye on patients for any problems or changes. Patients with problems may suffer symptoms like:<\/p>\n<div class=\"well\">\n<ul>\n<li>Pain in or around the elbow joint<\/li>\n<li>Loss of function<\/li>\n<li>Instability<\/li>\n<\/ul>\n<\/div>\n<p>As the medical device alert is not classed as extremely serious, patients who already have the implants are not required to have replacement surgery, but it&#8217;s recommended for those suffering from symptoms like those mentioned above to seek advice. Healthcare institutions are encouraged to monitor patients every six months for up to two years after having the DePuy prosthetic inserted.<\/p>\n<p>The loosening of the prostheses may lead to all sorts of problems including:<\/p>\n<div class=\"well\">\n<ul>\n<li>Osteolysis<\/li>\n<li>Poor Joint Mechanics<\/li>\n<li>Bone Fracture<\/li>\n<li>Soft tissue damage or irritation<\/li>\n<\/ul>\n<\/div>\n<p>Patients must not hide symptoms and must inform healthcare practitioners of any issues in order to prevent any lasting injuries that may have a life-changing effect. Thankfully, there have been no reports of adverse effects at the time of issuing the medical alert (12<sup>th<\/sup> June 2017).<\/p>\n<p>Whilst it has not yet been disclosed how many of the implants are out there, or have already been implanted, the recalled devices have only been on the market for less than two years. However, the recall is for all lots and batches of the affected implants.<\/p>\n<p>The medical device alert also requests practitioners find and return affected products back to DePuy Synthes and notify the company of any problems any implanted patients have suffered.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for radial head elbow artificial replacements amidst concerns over post-operative loosening of the device. Manufactured by DePuy company Synthes, the implants are suspected to loosen at the stem of the implant where it joins the bone. The Straight Radial Stem and the Curved &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/depuy-synthes-elbow-implants-mhra-recall\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">DePuy Synthes elbow implants recalled by the MHRA<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":804,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[5],"tags":[8],"class_list":["post-800","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-recalls"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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PFNA's are metal devices inserted into the femur bone to strengthen it. The U.K.'s Medicines and Healthcare Products Regulation Agency (MHRA) has noted a defect with the medical\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"elbow implants recall","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/elbow-implants-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/elbow-implants-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/elbow-implants-recall-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/elbow-implants-recall-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1754,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/elbow-implant-problems-and-stryker-recall","url_meta":{"origin":800,"position":1},"title":"Elbow implant problems and Stryker recall","author":"Author","date":"1st April 2019","format":false,"excerpt":"If you\u2019re suffering with elbow implant problems, you may want to read this. The recent Stryker recall could be linked to any complications you\u2019re experiencing. Back in November 2017, a Field Safety Notice was filed for a recall of the rHead Radial Head and the Uni-Elbow prosthesis. In February this\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical device alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":456,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/lawsuits-against-jj-defective-hip-implants","url_meta":{"origin":800,"position":2},"title":"Lawsuits against J&#038;J for defective hip implants","author":"Author","date":"9th January 2017","format":false,"excerpt":"J&J has had a rough time of late with the J&J talcum-powder lawsuit in which victims argued the use of such powder was a strong cause for ovarian cancer. On top of that we have the ongoing cases for hip replacement products that have been pursued across the world for\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/nhs-pelvic-floor-prolapse-recall.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/nhs-pelvic-floor-prolapse-recall.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/nhs-pelvic-floor-prolapse-recall.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/nhs-pelvic-floor-prolapse-recall.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":669,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/product-liability-claims-for-zimmer-knee-replacement-implants","url_meta":{"origin":800,"position":3},"title":"Lawyers seeking product liability claims against Zimmer for problems associated with their knee replacement implants","author":"Admin","date":"22nd May 2017","format":false,"excerpt":"Zimmer NexGen knee implants are supposed to provide patients with new artificial knees to last at least 15-20 years. However, there have been numerous reports that the implants have been loosening; causing pain, discomfort and other complications. With the level of complaints, the implants are believed to be defective and\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"zimmer nexgen knee implant claims","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/zimmer-nexgen-knee-implant-claims-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/zimmer-nexgen-knee-implant-claims-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/zimmer-nexgen-knee-implant-claims-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/zimmer-nexgen-knee-implant-claims-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1797,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/stanmore-hip-implant-recall","url_meta":{"origin":800,"position":4},"title":"Stanmore hip implant recall","author":"Author","date":"1st July 2019","format":false,"excerpt":"The Stanmore hip implant recall published earlier this year relates to the potential for some Modular Femoral Heads being contained in the incorrect packaging. The urgent Field Safety Notice issued by Stanmore Implants \u2013 who are a part of the Stryker Corporation \u2013 outlines the issue and the potential dangers.\u2026","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/health"},"img":{"alt_text":"hip replacement claims","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/hip-replacement-claims-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/hip-replacement-claims-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/hip-replacement-claims-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/hip-replacement-claims-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":677,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medtronic-adjustable-pressure-valves-worldwide-recall","url_meta":{"origin":800,"position":5},"title":"Medical device maker Medtronic has recalled their adjustable pressure valves across the world","author":"Admin","date":"24th May 2017","format":false,"excerpt":"Medtronic has issued a worldwide recall over their unused StrataMR valve devices after numerous complaints have been raised. In one of the complaints, one patient death is suspected to be related to the device. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent Field Safety Notice to\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"Royal Derby Hospital gynaecologist","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medtronic-valve-device-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medtronic-valve-device-recall-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medtronic-valve-device-recall-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medtronic-valve-device-recall-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/800","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=800"}],"version-history":[{"count":4,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/800\/revisions"}],"predecessor-version":[{"id":806,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/800\/revisions\/806"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/804"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=800"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=800"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}