• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips

Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips

September 25, 2012 By Arezu Sarvestani

Updated September 25, 2012, at 5:45 p.m. with comment from Smith & Nephew.

hips xray illustration

Smith & Nephew (FTSE:SN, NYSE:SNN) issued an "Urgent Field Safety Notice" for its Birmingham Hip Modular Head implants, part of the suite of devices that pioneered the metal-on-metal hip field when they 1st hit the market in 1997.

The orthopedic giant warned the Hong Kong department of health that new data on the implants, gathered since 2010, suggests a 1.29% failure rate based on the National Joint Registry of England and Wales and a 1.12% failure rate based on the Australian Orthopaedic Association’s National Joint Replacement Registry.

On their own the rates exceed the 1% benchmark established by the U.K.’s National Institute for Health and Clinical Excellence. Prior to 2010 registry data showed a 1% revision rate for the devices, according to the company.

"Smith & Nephew’s highest priority is to deliver safe and effective medical technology to benefit patients," Smith & Nephew spokesman Joe Metzger told MassDevice.com today. "As such, we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision."

Smith & Nephew did not issue a recall on the device, but updated its indications for use. The company noted that, when used strictly with the Smith & Nephew’s Synergy stems, the hip implants exhibited a 1.07% failure rate, which is within acceptable limits.

"The potential risks that may result from use of the device have not changed," according to a letter the company sent to healthcare providers. "They may include pain and limited mobility, potentially leading to revision surgery. Females of child bearing age  are  at greater risk  with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery."

The new indications on the Birmingham Hip Modular Heads restricts use only to revision surgeries "in cases where a Birmingham Hip Resurfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an uncemented Synergy stem," according to a Smith & Nephew web page.

The re-labeling does not change current practice for follow-up care for the Birmingham Hip Modular Head devices, Metzger told us.

"This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure," he added. "This change does not apply to our BHR resurfacing device, which is performing very well, and is supported by data from several registries and independent, peer-reviewed articles."

The alert is a new blow in the ongoing MoM implant controversy that has embroiled several orthopedic device makers, most notably Johnson & Johnson‘s (NYSE:JNJ) subsidiary DePuy Orthopaedics, in a flurry of lawsuits and public outcry.

As the 1st MoM hip implant to hit the global market, a knock against Smith & Nephew’s Birmingham devices may portend a fatal blow to the suite of products that followed, including those by Biomet Inc., Encore Medical, Wright Medical (NSDQ:WMGI) and Zimmer (NYSE:ZMH).

The Birmingham implants 1st hit the world in 1997, pioneered in Birmingham, England, by McMinn in a back-yard shed. McMinn believed that the risk of metal ions being introduced into patients’ bodies could be minimized with a design that kept the metal surfaces apart.

Rival orthopedic devices maker Wright Medical (NSDQ:WMGI) sought to block Smith & Nephew from getting its Birmingham metal-on-metal hip implant into the U.S. marketplace, according to filings with the FDA. Wright filed a citizen’s petition alleging that the study behind the PMA application was inadequate to prove safety and effectiveness.*

Correction, September 25, 2012, 5:00 p.m.: This article’s final paragraphs mistakenly used data about Smith & Nephew’s Birmingham Hip Resurfacing device in reference to the Birmingham Hip Modular Head implant.

Filed Under: Implants, Metal-on-Metal, News Well Tagged With: Hips, Smith & Nephew, Warning Letter

In case you missed it

  • House committee investigates $70M federal contract for AutoMedx ventilators
  • Edwards Lifesciences misses on earnings in Q4
  • COVID-19 assays sales power Hologic to Street-beating Q1
  • Stryker beats the Street on earnings but misses on revenue in Q4
  • How CGMs can inspire lifestyle changes
  • Johnson & Johnson gearing up for COVID-19 vaccine data announcement
  • Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer
  • Adapting to Pharma’s Next Normal – 2021 Pharmaceutical Trends
  • COVID-19 test sales boost Abbott in Street-beating Q4
  • Varian posts mixed bag Q1 results, expects Siemens Healthineers takeover to complete in early 2021
  • BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
  • Titan Medical closes on $11.5M offering
  • GE ticks up on mixed-bag Q4
  • BD CEO Polen to also serve as board chair
  • Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants  
  • Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
  • Longeviti Neuro Solutions ClearFit implant wins FDA clearance for use in ultrasound

RSS From Medical Design & Outsourcing

  • House committee investigates $70M federal contract for AutoMedx ventilators
    A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19. The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to… […]
  • How CGMs can inspire lifestyle changes
    As an early adopter of fitness trackers such as the Fitbit, I’ve long appreciated the power of health data. But my recent experience with a continuous glucose monitor (CGM) has done far more to inspire me to look after my health — even as a nondiabetic. I had heard about the potential of such technology… […]
  • COVID-19 mask factory opens in N.J.
    Hudson Holdings Group today announced it has opened a factory to make up to tens of millions of protective masks a month. The Piscataway, N.J., site will produce more than 200 jobs, according to the company, which is in partnership on the project with the State of New Jersey. “Our ultimate goal is to help,”… […]
  • TE Connectivity posts Street-beating Q1 results, medical sales dip 12%
    TE Connectivity (NYSE:TEL) posted first-quarter results today that beat the consensus on Wall Street. The Schaffhausen, Switzerland-based company reported profits of $381 million, or $1.13 per share, on sales of $3.5 billion for the three months ended Dec. 31, 2020, for a bottom-line gain of 1365.4% sales growth of 11.2% compared with Q1 2020. Adjusted to… […]
  • Could this 3-D printed ‘biomesh’ minimize hernia repair complications?
    Some hernia mesh implants have been associated with adverse post-surgical complications. So researchers at Baylor College of Medicine have developed a 3D-printed biomesh to support and reinforce the damaged abdominal wall and facilitate the healing process. Mesh implants may fail because they promote the adhesion of the intestine, liver or other visceral organs to the… […]
  • Superior Sensor Technology launches versatile differential pressure sensors
    Superior Sensor Technology (Santa Clara, Calif.) today announced the launch of differential pressure sensors for industrial applications that support up to seven selectable pressure ranges in one device. Designed for a wide range of applications, the new ND Series sensors support pressure ranges as low as 62.5 Pa/0.25” H2O to as high as 345 mBar/5… […]
  • BD touts study of antigen test over molecular test for identifying infectious COVID-19 cases
    Becton Dickinson (BD) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2. The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth… […]
  • TDK adds pressure sensors for ventilators
    TDK Corporation announced the launch of a new range of differential pressure sensors designed as printed circuit boards for use in medical devices. The sensors are designed for measurement ranges of 16 mbar full-scale (FS), 100 mbar FS and 7 bar FS, with accuracy of up to ±1% FS at temperatures from -20 °C to… […]
  • Pediatric device workshop scheduled for February
    A virtual public meeting on pediatric medical device development is scheduled for Feb. 9-11, 2021. Sponsors include the FDA, AdvaMed, the American Academy of Pediatrics and the Critical Path Institute, a public-private partnership that receives FDA funding. The System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) Virtual Workshop will focus on the… […]
  • Pedra wins breakthrough nod for perfusion system
    Singapore-based Pedra Technology announced today that the FDA has granted the company breakthrough device designation for the periprocedural use of its Xauron perfusion system in the treatment of critical limb-threatening ischemia (CLTI). CLTI is a severe form of peripheral artery disease (PAD) that is defined as ischemic rest pain, tissue loss or gangrene (tissue death) that… […]
  • Freudenberg Medical expands U.S. molding operations
    Freudenberg Medical announced that it has expanded injection molding operations at its Baldwin Park, Calif., operation, which is focused on thermoplastics. Freudenberg Medical Baldwin Park has added six injection molding machines including three new Arburg molding machines, a work cell for two-shot molding and a Wittmann Battenfeld micro-molding machine with in-process visual inspection capability. The… […]

Leave a Reply Cancel reply

You must be logged in to post a comment.

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS