Zimmer Biomet's Hip Replacement Device Increases Risk of Thigh Fracture, FDA Says

Dow Jones09-18 03:20

By Connor Hart

The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture.

The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement devices of a similar design. If a fracture occurs, additional surgical intervention will likely be needed, it added.

The FDA's finding comes after Warsaw, Ind.-based Zimmer Biomet in July initiated a voluntary recall to update instructions for use for the CPT Hip System because of an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by the end of the year.

The FDA recommended patients and caregivers discuss the benefits and risks of all available hip replacement devices, and that health-care providers and facilities consider using an alternative prosthesis where possible.

The agency said it will continue monitoring and reviewing data regarding the device's performance, and work with Zimmer Biomet to address its concerns.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

September 17, 2024 15:20 ET (19:20 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2468139617?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-09-18 03:20","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2468139617","market":"sh","top_or_hot":-1,"title":"Zimmer Biomet's Hip Replacement Device Increases Risk of Thigh Fracture, FDA Says","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Connor Hart \n</p>\n<pre>\n \n</pre>\n<p>\n  The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture. \n</p>\n<p>\n  The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement devices of a similar design. If a fracture occurs, additional surgical intervention will likely be needed, it added. \n</p>\n<p>\n  The FDA's finding comes after Warsaw, Ind.-based Zimmer Biomet in July initiated a voluntary recall to update instructions for use for the CPT Hip System because of an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by the end of the year. \n</p>\n<p>\n  The FDA recommended patients and caregivers discuss the benefits and risks of all available hip replacement devices, and that health-care providers and facilities consider using an alternative prosthesis where possible. \n</p>\n<p>\n  The agency said it will continue monitoring and reviewing data regarding the device's performance, and work with Zimmer Biomet to address its concerns. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Connor Hart at connor.hart@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  September 17, 2024 15:20 ET (19:20 GMT)\n</p>\n<p>\n  Copyright (c) 2024 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Zimmer Biomet's Hip Replacement Device Increases Risk of Thigh Fracture, FDA Says</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nZimmer Biomet's Hip Replacement Device Increases Risk of Thigh Fracture, FDA Says\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-18 03:20 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://dowjonesnews.com/newdjn/logon.aspx?AL=N><strong>Dow Jones</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By Connor Hart \n\n\n \n\n\n  The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture. \n\n\n  The agency on ...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00B19Z3581.USD","symbol_name":"Legg Mason ClearBridge - Value A Acc USD","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2468139617","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2468139617","pubTimestamp":1726600800,"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture.The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement devices of a similar design. If a fracture occurs, additional surgical intervention will likely be needed, it added.The FDA's finding comes after Warsaw, Ind.-based Zimmer Biomet in July initiated a voluntary recall to update instructions for use for the CPT Hip System because of an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by the end of the year.The FDA recommended patients and caregivers discuss the benefits and risks of all available hip replacement devices, and that health-care providers and facilities consider using an alternative prosthesis where possible.The agen","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0792757196.USD":"TEMPLETON SHARIAH GLOBAL EQUITY FUND \"A\" (USD) ACC","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU0310800379.SGD":"FTIF - Templeton Global A Acc SGD","BK4585":"ETF&股票定投概念","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","LU0310799852.SGD":"FTIF - Templeton Global Equity Income A MDIS SGD","LU1267930813.SGD":"FRANKLIN TEMPLETON SHARIAH GLOBAL EQUITY \"AS\" (SGD) ACC","BK4566":"资本集团","BK4082":"医疗保健设备","LU1267930573.SGD":"TEMPLETON GLOBAL \"AA\" (SGD) ACC A","BK4588":"碎股","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0006061336.USD":"Blackrock US Small and MidCap Opportunities A2 USD","LU1267930490.SGD":"TEMPLETON GLOBAL EQUITY INCOME \"AS\" (SGD) INC A","LU0211327993.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (USD) ACC","LU0708994859.HKD":"TEMPLETON GLOBAL \"A\" (HKD) ACC","ZBH":"齐默巴奥米特控股","BK4504":"桥水持仓","LU0029864427.USD":"TEMPLETON GLOBAL \"A\" (USD) INC","LU0211328371.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (MDIS) (USD)   INC","LU0889566641.SGD":"FTSF - Templeton Shariah Global Equity A Acc SGD","LU0128525929.USD":"TEMPLETON GLOBAL \"A\" (USD) ACC"},"translate_title":"FDA称Zimmer Biomet的髋关节置换设备会增加大腿骨折的风险","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ZBH":1},"content_text":"By Connor Hart \n\n\n \n\n\n  The Food and Drug Administration said hip replacement surgeries that use Zimmer Biomet's CPT Hip System result in a higher risk of thigh bone fracture. \n\n\n  The agency on Tuesday said recent research found a higher risk of thigh bone fracture with the device -- Zimmer Biomet's CPT Hip System Femoral Stem 12/14 Neck Taper -- compared with hip replacement devices of a similar design. If a fracture occurs, additional surgical intervention will likely be needed, it added. \n\n\n  The FDA's finding comes after Warsaw, Ind.-based Zimmer Biomet in July initiated a voluntary recall to update instructions for use for the CPT Hip System because of an increased risk of thigh bone fracture. The manufacturer also announced its plan to phase out the sale of the device by the end of the year. \n\n\n  The FDA recommended patients and caregivers discuss the benefits and risks of all available hip replacement devices, and that health-care providers and facilities consider using an alternative prosthesis where possible. \n\n\n  The agency said it will continue monitoring and reviewing data regarding the device's performance, and work with Zimmer Biomet to address its concerns. \n\n\n \n\n\n  Write to Connor Hart at connor.hart@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  September 17, 2024 15:20 ET (19:20 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.26.4","shortVersion":"4.26.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2468139617"}