Navigation Links
Law Offices of John David Hart: What Went Wrong with the Stryker ShapeMatch Cutting Guides?
Date:8/23/2013

FORT WORTH, Texas, Aug. 23, 2013 /PRNewswire/ -- The Stryker ShapeMatch Cutting Guides are single-use, disposable cutting guides intended to help a surgeon mark the bone before cutting during a total knee replacement surgery.  The guides ultimately assist the surgeon in the positioning of the total knee replacement components.  The cutting guides are manufactured for patients individually based on imaging studies of the patients' knee.  The ShapeMatch software program uses the imaging studies to create a three-dimensional model of the patient's knee. 

The ShapeMatch Cutting Guides were manufactured and distributed from May 2011 to November 2012.  Adverse event reports submitted to the U.S. Food and Drug Administration ("FDA") have indicated that surgeons who discovered that the parameters of the cutting guide were incorrect were forced to make modifications in order to complete the knee replacement surgery.   A defect in the ShapeMatch software was responsible for the incorrect cutting guide parameters. 

As a result, in November 2012, Stryker emailed surgeons and imaging centers advising them to stop prescribing, planning or performing operative or imaging procedures with the ShapeMatch Cutting Guides until further notice.  Subsequently, on April 10, 2013, Stryker issued an Urgent Medical Device Recall of the ShapeMatch Cutting Guides.

Due to the defect in the ShapeMatch Cutting Guides, patients may experience adverse health consequences including joint instability, fracture, the need for revision surgery and chronic pain and limitations with mobility.  Stryker recommends that patients who are experiencing symptoms contact their surgeon for evaluation.

The ShapeMatch Cutting Guide was used exclusively with the Stryker Triathlon Knee System.  However, the Stryker Triathlon Knee System is not subject to a recall. 

The FDA has class
'/>"/>

SOURCE The Law Offices of John David Hart
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. ImmusanT Relocates Offices to State-of-the-Art Innovation Facility
2. Voss Law Firm, P.C. Moves Offices in The Woodlands, Texas
3. The Law Offices of Barry Fischer files Federal Complaint on behalf of L.A.-based pot dispensary
4. Screenflex Portable Room Dividers Create "Private Doctors Offices" In Pharmacies During Busy Flu Season
5. The Law Offices of Marc S. Henzel Announces Class Action Lawsuit Against Aveo Pharmaceuticals, Inc. and Certain Officers -- (Nasdaq: AVEO) was filed on behalf of stockholders
6. Medbox and AVT Develop Secure, Automated Medicine Sample Dispenser for Doctors Offices
7. David F. Harty Joins Systech International as Vice President
8. Dr. David Brailer and Stephen Dubner Keynotes for NYeC 2012 Digital Health Conference
9. WebMD Taps David C. Marek to Assume Consumer Leadership Role
10. arGEN-X Appoints Dr. David L. Lacey to its Supervisory Board
11. Alliqua Names David Johnson Executive Chairman of Aquamed Technologies and Member of Alliqua Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... 2014  Abaxis, Inc. (NasdaqGS: ABAX ), ... for the medical, research, and veterinary markets worldwide and ... markets in the United States , ... agreement with Patterson Veterinary Supply. Patterson ... of Abaxis veterinary products throughout the United ...
(Date:10/1/2014)... DIEGO , Oct. 1, 2014  ResMed (NYSE: ... sleep and the first company to design complete sleep apnea ... educate women about the importance of a good night,s sleep. ... will challenge the myth that feeling tired is just part ... understand that sleep is a critical pillar of health, essential ...
(Date:10/1/2014)...   Cypher Genomics, Inc., the genome informatics ... Ravenel as chief technology officer. Ravenel has more ... and a proven track record of designing and architecting ... has been recognized as a top designer and architect ... industry-wide for delivering innovative products that operate at scale ...
Breaking Medicine Technology:Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 2Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 3Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 4ResMed Launches Initiative to Help Women Get Better Sleep 2ResMed Launches Initiative to Help Women Get Better Sleep 3Cypher Genomics Appoints J. Patrick Ravenel Chief Technology Officer 2
... Romark Laboratories, L.C., a,privately-owned biopharmaceutical company, today ... clinical trial to evaluate the safety and,efficacy of ... in,U.S. patients with chronic hepatitis C genotype 1 ... of care therapy (peginterferon and,ribavirin). The company expects ...
... Urologist Presents OrBIT Study Results Comparing Percutaneous, Tibial Nerve ... ... Meeting, MINNEAPOLIS, May 21 Uroplasty, Inc. (Amex:,UPI), ... proprietary products for the treatment of voiding dysfunction,today highlighted ...
Cached Medicine Technology:Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders 2Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders 3Uroplasty Highlights Clinical Results From a Study of the Urgent(R) PC Neuromodulation System 2Uroplasty Highlights Clinical Results From a Study of the Urgent(R) PC Neuromodulation System 3
(Date:10/2/2014)... Steven Reinberg HealthDay Reporter ... to a major highway may raise your risk for high ... 5,000 postmenopausal women, those who lived within 109 yards of ... developing high blood pressure than women living at least half ... this study highlight the importance of our physical environment on ...
(Date:10/2/2014)... Dennis Thompson HealthDay Reporter ... and the District of Columbia now have a total of ... that has been infecting children since the summer, U.S. ... virus have died in recent weeks, but it,s not clear ... those deaths, officials said. Health officials are also trying ...
(Date:10/1/2014)... An international team of scientists has shown that more ... treated with existing drugs. , The study found that ... cancers with a genetic mutation that is present in ... JAK inhibitors are currently used, or are in clinical ... and myeloproliferative disorders. , Bowel cancer is the second-most ...
(Date:10/1/2014)... Patients with increased inflammation, including those receiving cytokines ... of depression. For example, a 6-month treatment course ... infection causes depression in approximately 30% of patients. ... as fish oil, have a long list of ... disease and reducing triglyceride levels. These nutritional compounds ...
(Date:10/1/2014)... October 01, 2014 Marriagelifeinsurance.com has ... life insurance for retired couples. , Senior citizens ... financial security for their loved ones. A joint policy ... insured persons pass away. , Life insurance can ... life insurance can even be purchased online, as the ...
Breaking Medicine News(10 mins):Health News:Living Near a Highway May Be Bad for Your Blood Pressure 2Health News:Living Near a Highway May Be Bad for Your Blood Pressure 3Health News:42 States Reporting Respiratory Virus That Targets Kids 2Health News:42 States Reporting Respiratory Virus That Targets Kids 3Health News:Eighty percent of bowel cancers halted with existing medicines 2Health News:Omega-3 fatty acids may prevent some forms of depression 2Health News:Elderly Life Insurance - Find Life Insurance for Retired Couples! 2
... News) -- Bats and dolphins aren,t the only mammals that ... identify objects and navigate unfamiliar surroundings. Researchers have found ... published online May 25 in PLoS ONE , found ... the faint returning echoes, blind people were able to map ...
... drug that is commonly used to prevent organ transplantation ... finding from UNC scientists was reported in the May ... of surgery, said, " We now have a rationale ... reduces breast cancer growth in humans. Since Tacrolimus is ...
... converging in patient care at a faster pace than ... point-of-care health technologies like telemedicine to medical robots performing ... What,s next? Ask NJIT Distinguished Professor Atam Dhawan, ... Albert Dorman Honors College, chair of the the ...
... , THURSDAY, May 26 (HealthDay News) -- Caffeine, a ... nausea, anxiety and depression. Now, new research reveals that caffeine ... pregnant. By analyzing fallopian tubes in mice, researchers found ... from the ovaries through the fallopian tubes and into the ...
... News)-- Lists of the side effects for prescription medications ... an average of 70 per medication, a new study reports. ... and consumers of potential hazards, but this expansion may have ... health concerns, say the study authors, who argue the information ...
... that has been on the market for decades to treat ... be a possible therapy for vascular diseases, including atherosclerosis and ... Previously, researchers discovered that retinoids commonly used natural ... vascular disease by spurring into action a very particular segment ...
Cached Medicine News:Health News:Blind People May Be Able to Use Echoes to Identify Objects 2Health News:Common transplant drug inhibits breast cancer growth, UNC laboratory study shows 2Health News:5 new hot spots where medicine and technology will converge 2Health News: Caffeine May Interfere With Fertility in Women 2Health News:Lists of Prescription Meds' Side Effects Keep Growing: Study 2Health News:Multitasking meds: Scientists discover how drug for leukemia, psoriasis, may tackle vascular disease 2Health News:Multitasking meds: Scientists discover how drug for leukemia, psoriasis, may tackle vascular disease 3
.90mm (20G) guillotine cutting probe with 1.4mm (17G) removable irrigation sleeve...
Cannula: .90mm x 28mm (20 G x 1 1/8 in) Handle: 9.3cm (3 5/8 in) long, Flute, .90 x 28mm, vacuum handle [Charles]...
...
Designed for stab incisions...
Medicine Products: