{"id":1681,"date":"2018-11-09T07:00:26","date_gmt":"2018-11-09T07:00:26","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1681"},"modified":"2018-11-08T12:08:49","modified_gmt":"2018-11-08T12:08:49","slug":"bone-cement-complications-from-product-recall","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/bone-cement-complications-from-product-recall","title":{"rendered":"Bone cement complications from product recall"},"content":{"rendered":"<p>A regulator warning earlier this year stemmed from bone cement complications caused by an issue with the product itself.<\/p>\n<p>A risk of the need for revision surgery from the use of Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision was identified. Manufacturer, Biomet UK Limited, issued a Field Safety Notice at the end of last year. The UK\u2019s medical regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), issued their own recall advice off the back of the findings.<\/p>\n<p>Anyone who has suffered with bone cement complications may find the reason is to do with the product itself as opposed to failed surgery.<\/p>\n<p><!--more--><\/p>\n<h3><strong>Bone cement complications arising from recall<\/strong><\/h3>\n<p>The bone cement complications arising from the recall mean that the mechanical strength of the affected batches of cement may be reduced. This means there\u2019s a risk of a patient being forced to undergo revision surgery.<\/p>\n<p>There\u2019s also the risk of surgery being prolonged as a result of increased polymerisation time when using the recalled batches. In short, this means the cement isn\u2019t &#8216;setting&#8217; quickly enough as a result of the problems identified.<\/p>\n<p>As a result of the bone cement issues identified, surgeons have been instructed to create risks assessments and follow-up plans for affected patients.<\/p>\n<h3><strong>Have you been affected by the bone cement complications?<\/strong><\/h3>\n<p>If you&#8217;ve had to have revision surgery or had prolonged surgery as a result of the bone cement complications, we may be able to help you.<\/p>\n<p>Particularly in cases where revision surgery is required, there may be a claim for personal injury compensation. The simple fact is that the need for revision surgery has stemmed from the product problem.<\/p>\n<p><strong><a href=\"https:\/\/www.groupactionlawyers.co.uk\/contact\" target=\"_blank\" rel=\"noopener\">You can contact our team for help and advice today.<\/a> <\/strong><\/p>\n<p>In medical defect cases, claiming compensation for the need for further surgery can be common. This was a common factor in the PIP breast Implant litigation that we\u2019ve so far recovered over \u00a31.3m in damages for. Women were required to have new implants fitted and the defective ones removed.<\/p>\n<h3><strong>Products linked to the bone cement complications<\/strong><\/h3>\n<p>The specific products linked to the bone cement complications and the MHRA recall are as follows:<\/p>\n<table width=\"630\">\n<thead>\n<tr>\n<td><strong>Catalogue number (Manufacturer product code)<\/strong><\/td>\n<td><strong>Product Description<\/strong><\/td>\n<td><strong>Batch\/Lot number<\/strong><\/td>\n<td><strong>Use-by date<\/strong><\/td>\n<td><strong>Date of manufacture<\/strong><\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>OPTIPAC 40 REFOBACIN REVISION<\/td>\n<td>4730501163-1<\/td>\n<td>A648C04670<\/td>\n<td>31\/05\/2018<\/td>\n<td>19\/12\/2016<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 40 REFOBACIN REVISION<\/td>\n<td>4730501163-1<\/td>\n<td>A648C05100<\/td>\n<td>30\/06\/2018<\/td>\n<td>09\/01\/2017<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 40 REFOBACIN REVISION<\/td>\n<td>4730501163-1<\/td>\n<td>A705B05130<\/td>\n<td>31\/07\/2018<\/td>\n<td>09\/02\/2017<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 40 REFOBACIN REVISION<\/td>\n<td>4730501163-1<\/td>\n<td>A705B06130<\/td>\n<td>30\/09\/2018<\/td>\n<td>04\/04\/2017<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 40 REFOBACIN REVISION<\/td>\n<td>4730501163-1<\/td>\n<td>A722B08920<\/td>\n<td>30\/11\/2018<\/td>\n<td>20\/06\/2017<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 80 REFOBACIN REVISION<\/td>\n<td>4732501165-1<\/td>\n<td>A620A01788<\/td>\n<td>31\/01\/2018<\/td>\n<td>16\/08\/2016<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 80 REFOBACIN REVISION<\/td>\n<td>4732501165-1<\/td>\n<td>A620A0178A<\/td>\n<td>31\/01\/2018<\/td>\n<td>23\/08\/2016<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 80 REFOBACIN REVISION<\/td>\n<td>4732501165-1<\/td>\n<td>A705C05628<\/td>\n<td>31\/08\/2018<\/td>\n<td>30\/03\/2017<\/td>\n<\/tr>\n<tr>\n<td>OPTIPAC 80 REFOBACIN REVISION<\/td>\n<td>4732501165-1<\/td>\n<td>B705B05128<\/td>\n<td>31\/07\/2018<\/td>\n<td>09\/02\/2017<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><a href=\"https:\/\/www.gov.uk\/drug-device-alerts\/bone-cement-optipac-40-refobacin-revision-and-optipac-80-refobacin-revision-risk-of-revision\" target=\"_blank\" rel=\"noopener\"><strong>Information from MHRA Website.<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A regulator warning earlier this year stemmed from bone cement complications caused by an issue with the product itself. A risk of the need for revision surgery from the use of Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision was identified. Manufacturer, Biomet UK Limited, issued a Field Safety Notice at the end of &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/bone-cement-complications-from-product-recall\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Bone cement complications from product recall<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1520,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[5,27,10],"tags":[25,58,54,60,61,20,8],"class_list":["post-1681","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","category-products","category-recalls","tag-device-alerts","tag-medical-devices","tag-medical-implants","tag-medical-product","tag-medical-recall","tag-mhra","tag-recalls"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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What is the CPT Hip System Femoral Stem?\u2026","rel":"","context":"In &quot;Group Actions&quot;","block_context":{"text":"Group Actions","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/group-actions"},"img":{"alt_text":"CPT Hip System Femoral Stem","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Lawyer-Professional-Person-Meeting-27.jpg?fit=1200%2C883&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Lawyer-Professional-Person-Meeting-27.jpg?fit=1200%2C883&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Lawyer-Professional-Person-Meeting-27.jpg?fit=1200%2C883&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Lawyer-Professional-Person-Meeting-27.jpg?fit=1200%2C883&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Lawyer-Professional-Person-Meeting-27.jpg?fit=1200%2C883&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":1754,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/elbow-implant-problems-and-stryker-recall","url_meta":{"origin":1681,"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":1794,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/ethicon-surgical-staplers-medical-device-alert","url_meta":{"origin":1681,"position":2},"title":"Ethicon surgical staplers medical device alert","author":"Author","date":"25th June 2019","format":false,"excerpt":"A medical device alert has been issued and published by the MHRA in relation to Ethicon surgical staplers, which have reportedly caused injury to some patients. It\u2019s understood that there\u2019s a risk that some of the devices manufactured from March 2018 have not been working properly. Reported issues include the\u2026","rel":"","context":"In &quot;Group Actions&quot;","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":2080,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/the-difficulties-of-vaginal-mesh-removal","url_meta":{"origin":1681,"position":3},"title":"The difficulties of vaginal mesh removal","author":"Author","date":"23rd March 2021","format":false,"excerpt":"As stories of vaginal mesh complications continue to emerge, many of those who have suffered from the implants are seeking treatment to lessen or stop the pain and injuries they have faced. However, the difficulties of vaginal mesh removal can mean that some of the harmful consequences are, unfortunately, irreversible.\u2026","rel":"","context":"In &quot;Group Actions&quot;","block_context":{"text":"Group Actions","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/group-actions"},"img":{"alt_text":"pelvic mesh inquiry vaginal mesh implants concerns","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/vaginal-mesh-implants-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\/vaginal-mesh-implants-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/vaginal-mesh-implants-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/vaginal-mesh-implants-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":800,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/depuy-synthes-elbow-implants-mhra-recall","url_meta":{"origin":1681,"position":4},"title":"DePuy Synthes elbow implants recalled by the MHRA","author":"Admin","date":"10th July 2017","format":false,"excerpt":"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\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":2795,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/legency-remedies-eye-wash-recall","url_meta":{"origin":1681,"position":5},"title":"Legency Remedies Eye Wash Recall","author":"Author","date":"4th June 2024","format":false,"excerpt":"The safety of medical products is paramount, especially when they are meant to address critical health needs. We look at the Legency Remedies eye wash recall. When products like eye wash solutions are recalled due to safety concerns, individuals who have used them may face unforeseen health risks. If you\u2026","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/health"},"img":{"alt_text":"Legency Remedies eye wash recall","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Desk-Computer-Typing-13-Copy-min.png?fit=915%2C610&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Desk-Computer-Typing-13-Copy-min.png?fit=915%2C610&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Desk-Computer-Typing-13-Copy-min.png?fit=915%2C610&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-CEL-DBL-SEOSDB-Desk-Computer-Typing-13-Copy-min.png?fit=915%2C610&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\/1681","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\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=1681"}],"version-history":[{"count":1,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1681\/revisions"}],"predecessor-version":[{"id":1682,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1681\/revisions\/1682"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/1520"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}