{"id":1059,"date":"2017-11-03T11:29:24","date_gmt":"2017-11-03T11:29:24","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1059"},"modified":"2017-11-03T11:32:55","modified_gmt":"2017-11-03T11:32:55","slug":"mhra-medical-alert-comprehensive-nano-humeral-components","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/mhra-medical-alert-comprehensive-nano-humeral-components","title":{"rendered":"MHRA issues medical alert over Comprehensive Nano Humeral Components"},"content":{"rendered":"

The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components<\/em> over risks of needing revision surgery when used in reverse configuration.<\/p>\n

The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices.<\/p>\n

The comprehensive ‘nano humeral component’ is usually used in the anatomic or reverse configuration, but after an annual review was conducted, the study data indicated the device was not fit for use in the reverse configuration.
\n
\nThe study found that, of 44 devices implanted in the reverse configuration, five needed revision surgery. Hospitals and clinics are instructed not to use the devices in the ‘reverse configuration’<\/strong> but using it in the anatomic way is deemed safe for use and exceeds the expected performance rate. Zimmer Biomet is therefore carrying out a label correction with the updated instructions for the devices to only be installed one way.<\/p>\n

The alert warns of the most adverse consequence to be exposing patients of risk of the installed device loosening, requiring further surgery to correct the fault. The following comprehensive ‘nano humeral component PPS devices’ are affected by the alert:<\/p>\n

\n\n\n\n\n\n\n\n\n\n\n
Item Number<\/th>\nSize<\/th>\n<\/tr>\n<\/thead>\n
115730<\/td>\n30mm<\/td>\n<\/tr>\n
115732<\/td>\n32mm<\/td>\n<\/tr>\n
115734<\/td>\n34mm<\/td>\n<\/tr>\n
115736<\/td>\n36mm<\/td>\n<\/tr>\n
115738<\/td>\n38mm<\/td>\n<\/tr>\n
115740<\/td>\n40mm<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

Doctors and physicians are encouraged to monitor patients who have had the device implanted in the reverse configuration and are experiencing some loosening more than two years of having the device fitted. Patients should be told to let their doctors know of “any increased pain or loss of shoulder movement or if their shoulder suddenly changes shape.”<\/p>\n

For the patients, being implanted with an incorrectly configured device can be extremely disruptive. The pain and discomfort can prevent the patient from having full function of their shoulder and arm, making it difficult to work, lift or reach things. <\/p>\n

For patients who need revision surgery, they will probably need to take time off to attend a hospital or clinic. The invasive surgery would not have been necessary if Zimmer Biomed had identified the fault earlier and either instructed doctors not to use the device in the ‘reverse configuration’ at all or only produce those that were fully functional both ways.<\/p>\n

After the revision surgery, the patient may need time off to recuperate. Patients often forget they can claim financial compensation when a device has caused them harm to which they weren’t fully warmed about. <\/p>\n

In this instance, those who were not warned that the implants could come loose and lead to revision surgery could claim for the pain, financial expenses and loss of amenity resulting from the implant. <\/p>\n

This includes the costly trips to and from the hospital for the surgery and check-ups, taking time off work to attend these appointment and recovery, and even the help others have had to provide because of the patient’s loss of mobility.<\/p>\n","protected":false},"excerpt":{"rendered":"

The Medical Health products Regulatory Agency (MHRA) has issued a medical device alert over Zimmer Biomet made Comprehensive Nano Humeral Components over risks of needing revision surgery when used in reverse configuration. The manufacturer produced a medical device field safety notice earlier in June warning users of the less than accurate labelling on the devices. … Continue reading MHRA issues medical alert over Comprehensive Nano Humeral Components<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[25,20],"class_list":["post-1059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-device-alerts","tag-mhra"],"yoast_head":"\nMHRA Medical Alert For Comprehensive Nano Humeral Components<\/title>\n<meta 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Patients with this medical device potentially face some risks, and The Group Action Lawyers are assessing the situation. 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Reported issues include the\u2026","rel":"","context":"In "Group Actions"","block_context":{"text":"Group Actions","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/group-actions"},"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":[]},{"id":648,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-companies-wait-too-long-recall-defective-devices","url_meta":{"origin":1059,"position":3},"title":"Studies shows that companies wait too long to recall medical devices","author":"Admin","date":"10th May 2017","format":false,"excerpt":"How long is too long? It seems that medical device companies do not prioritise the safety of their products above profits and reputation, as a study conducted by the University of Minnesota revealed that these companies tend to delay in recalling defective products. When problems are not reported to relevant\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_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\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":327,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/22-12-16-updated-advice-on-the-recent-stockert-3t-heater-cooler-issues","url_meta":{"origin":1059,"position":4},"title":"Updated advice on the recent Stockert 3T heater-cooler issues","author":"Admin","date":"22nd December 2016","format":false,"excerpt":"The Stockert 3T heater-coolers used during certain surgeries have been linked to a dangerous microorganism, Mycobacterium chimaera. The manufacturers of the 'deadly device' have now issued advice in relation to managing and cleaning the device as part of ongoing investigations. Heater-coolers On 11 June 2015, the Medicines and Healthcare products\u2026","rel":"","context":"In "Medical"","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\/11\/battery-implants.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\/11\/battery-implants.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/battery-implants.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/11\/battery-implants.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1075,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/another-medical-device-alert-intra-aortic-balloon-pump-fault","url_meta":{"origin":1059,"position":5},"title":"Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!","author":"Admin","date":"10th November 2017","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet\/Getinge. The alert closely follows the one issued over the Datascope Corp's similar devices that were found to have an electrical fault. This new alert identifies a \"false blood detection\u2026","rel":"","context":"In "Medical"","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\/medical-device-alert-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\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-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\/1059","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=1059"}],"version-history":[{"count":4,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1059\/revisions"}],"predecessor-version":[{"id":1063,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1059\/revisions\/1063"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/389"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}