Archive for the ‘Medical Device Claims’ Category

We would like to hear from you if you received any Metal-On-Metal Hip Implant

August 2013

Please contact us for a free potential claim review if you received any type of Metal-On-Metal hip implant:

For example, we are interested in hearing from you if you or a loved one have a Stryker Rejuvenate / ABG II Hip Stem implant.

Roughly about 20,000 Rejuvenate and ABG II hip stems were involved in the Stryker Rejuvenate hip recall.  Please contact us today if you have any type of metal-on-metal hip implant.

Regardless of the type of metal-on-metal hip implant that you or a loved one have, we would like to speak with you if you have a metal-on-metal hip implant.  Please contact us today as statute of limitations periods may bar your claim if you wait.

NOW EVALUATING POTENTIAL MEDTRONIC INFUSE® BONE GRAFT CLAIMS

September 2012

THE MULLIGAN LAW FIRM IS NOW EVALUATING POTENTIAL MEDTRONIC INFUSE® BONE GRAFT CLAIMS

If you or a loved one have suffered an injury after use of a bone graft product, please call us immediately at 1-866-529-0001 or fill out any of the contact forms on this website.

Medtronic INFUSE® Bone Graft Genetically Engineered Morphogenic Protein Linked To Serious Side Effects

You may be entitled to compensation!

The Side-Effects of INFUSE® Morphogenic Protein

Some of the side effects potentially linked to INFUSE® Morphogenic Protein, include but are not limited to:


• Difficulty Breathing
• Difficulty Speaking
• Difficulty Swallowing
• Nerve Injuries
• Ectopic Or Uncontrolled Bone Growth
• Retrograde Ejaculation
Urogenital Injuries

• Chronic Pain, (Leg Or Arm Most Common)
• Neck Injuries
• Paralysis
• Cancer
• Severe Swelling With Related Severe Side Effects

Death


If you or a loved one have received INFUSE® or are unsure what kind of bone graft you received, but you have experienced injury, please contact us immediately for a free consultation.

Always consult with your licensed physician before you stop taking any medications, or using any medical device. If you or a loved one have suffered injury after receiving a bone graft, please contact The Mulligan Law Firm immediately via this website or 1-866-529-0001; Se Habla Espanol.

THE MULLIGAN LAW FIRM IS CURRENTLY EVALUATING DEPUY ASR AND ASRXL HIP IMPLANT POTENTIAL CLAIMS

September 2011

THE MULLIGAN LAW FIRM IS CURRENTLY EVALUATING DEPUY ASR AND ASRXL HIP IMPLANT POTENTIAL CLAIMS

The ASR hip cup is a metal-on-metal ball and socket, large diameter hip resurfacing device.

DePuy, the company that manufactures the ASR hip cup (pronounced dee-pew), was acquired by Johnson & Johnson in 1998.

The cause of the DePuy ASR / ASRXL Cup hip implant problem / failure issue is under investigation.

Metal debris early in the placement of this implant may cause inflammation, leading to damaged muscles and soft tissue.

The result?  An expensive and painful surgery intended to last at least a decade often requires revision within two to three years.

If you or a loved one has been adversely affected / injured after surgical implantation of a DePuy Acetabular Cup, please contact us immediately for a free consultation.

THE MULLIGAN LAW FIRM IS NOW EVALUATING / INVESTIGATING DEPUY ORTHOPAEDICS HIP DEVICE INJURY CLAIMS

March 2010

The DePuy Articular Surface Replacement Hip Implant is a hip replacement cup manufactured by DePuy, a division of Johnson & Johnson.  DePuy Orthopaedics withdrew the hip device after more than two years of reports that the hip implant, called an ASR, failed in patients only a few years after implant.  This failure required costly and painful replacement operations. 

The device was first used in the United States in 2005.

Withdrawn from the Australian Market in December 2009, it is under scrutiny in the U.S. and has been withdrawn from the domestic market.

The FDA has received, beginning in 2008, about 300 complaints about the early failure of the implanted device.

On March 9, 2010, DePuy announced that the DePuy ASR Hip Replacement would be discontinued in the U.S. market because it was failing and requiring remedial surgeries.

The same release mentions a higher failure rate in smaller-boned patients and those with certain bone weaknesses.

There is no FDA recall at this time.  Please check back at this website for updates from time to time.

The ASR hip cup is a metal-on-metal ball and socket, large diameter hip resurfacing device.

The cause of the DePuy ASR Cup hip implant failures is still not known. 
 
Metal debris early in the life of this implant can cause inflammation, leading to damaged muscles and soft tissue.

Among the primary and most serious side-effects mentioned in the ASR hip cup revision reports:

>Implanted cup loosening or failing to bond
>Pseudotumour: a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris.
>ALVAL (Aseptic Lymphocyte Dominated Vasculitis Associated Lesion): an adverse tissue reaction to metal particles and ions.
>Metallosis: condition of excessive metal debris.

If you or a loved one has been seriously injured after surgical implantation of a DePuy Acetabular Cup, please contact us immediately for a free consultation as soon as possible.

Denture Cream Injuries – Zinc Poisoning

February 2010

Various brands of denture creams help to adhere dentures to an individual’s gums and help stop pain and discomfort while wearing dentures. Zinc is found in some denture creams and can be harmful when individuals are exposed to toxic levels.

Fixodent® and Super Poligrip® are two denture creams that contain zinc.

Excessive zinc exposire can lead to several significant health problems.

Research has found that users of denture creams such as Fixodent® and Super Poligrip® are at risk for zinc poisoning.

Zinc Poisoning symptoms include:

- paralysis
- weakness in the extremities
- lack of coordination and/or poor balance
- pain in the extremities
- tingling or numbness
- difficulty urinating
- loss of sensation

Excess levels of Zinc in the blood can also result in the following diagnoses:

- ZINC POISONING
- MYELOPATHY (SPINAL CORD DAMAGE)
- COPPER DEFICIENCY – HYPOCUPREMIA
- NEUROPATHY
- ANEMIA
AND/OR
- BONE MARROW FAILURE

If you or a loved one have used denture creams of any kind and suffer from these or other significant symptoms / injuries, you may be entitled to compensation. Contact The Mulligan Law Firm immediately via this website or 1-866-529-0001, Ext. 245.  Se Habla Espanol

Zimmer Durom® Cup can cause major hip complications

September 2009

The Zimmer Durom® Cup is an artificial hip component used in hip replacement surgeries. It has been used in Total Hip Arthroplasty (THA) surgeries in the USA and overseas for hip resurfacings. Manufactured by Zimmer Holdings Ltd, it is a solid metal cup made from cobalt chromium alloy and sprayed with a titanium plasma-sprayed coating. It was introduced in 2006 and has been implanted in an estimated 12,000 patients.

Side Effects of the Zimmer Durom® Cup
The side effects reported with the Zimmer Durom® Cup were blood clots, infections, changing of leg length, feeling of the leg giving away, difficulty in climbing, pain in the groin, joint stiffening, loosening of the cup causing pain or even breakage of the Durom® cup inside the body. Many have been forced to have revision or additional surgery done to correct the problem. Usually, symptoms appeared after 90 days of surgery or more.

FDA & the Zimmer Durom® Cup
The Zimmer Durom® Cup was approved by the FDA in 2006. Later, Zimmer found itself under mounting FDA pressure, and on July 22, 2008,  temporarily suspended marketing and distribution of the device.

It also sent a letter to U.S. orthopedic surgeons asking them to stop using this product. However, this seemed just a cosmetic initiative as it later resumed sales shifting the blame onto surgical error for the problems.

Who We Are
Have you or your loved ones faced hip complications as a result of using the Zimmer Durom® Cup? Don’t wait, you could be potentially entitled to compensation.
Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Calaxo® Bone Screw Update

September 2009

Manufactured by Smith & Nephew, the Calaxo® screw (officially known as the Calaxo Bioabsorbable Interference Screw) was approved by the FDA and first made available for use in the U.S. in March of 2006. As soon as the screw began to be used in ACL (anterior cruciate ligament) knee surgery, reports began to come in about the Calaxo® screws breaking inside the body and causing severe knee pain.

The last FDA word on the Calaxo® Screw was in the March 26, 2008 FDA Weekly Enforcement Report. In it the FDA details the recall under RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II.

Here follows the FDA Enforcement Report for March 26, 2008:

Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

PRODUCT
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw (all the different sizes detailed)
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007.
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
REASON
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
VOLUME OF PRODUCT IN COMMERCE
68,285 units
DISTRIBUTION
Nationwide and Internationally

Comments on the listing above
In this short listing, the story is told. The manufacturer, Smith & Nephew, Inc, and the Endoscopy manufacturing division, located in Mansfield, MA, initiated a recall by letter on August 21 and then again on August 23, 2007. The company itself initiated the recall and the recall is ongoing.

Three reasons for the recall are given here:

First is mention of a post operative fluid pocket, fluid that in some cases built up in the body reaction to the implanted screw after surgery.

Additionally listed is “the potential for graft failure”, which could be talking about the side effect of infected or dead tissue or bone that has to be surgically removed (a process known as debridement).

The final mentioned reason, “premature material degradation”, means that in some cases the screws broke into pieces and had to be surgically removed

The number of units recalled is now known to be exactly 68,285 units.

The final note was that the Calaxo screw had been distributed both nationally and internationally – there is no mention of what other countries might have been affected, or what proportion of screws were distributed in the US versus abroad.

In any case, if you have reason to suspect that you or a loved one were implanted with one of these Calaxo Bioabsorbable Interference Screws in ACL surgery, surgery that almost certainly took place between March 2006 and November 2007, you may be entitled to compensation.

Contact Eric Gruenwald, Attorney / Lawyer at (866) 529-0001, EXT. 245, or by email at help@mulliganlaw.com for a free consultation.

Calaxo® bone screw can cause debilitating complications

September 2009

The Calaxo® Osteoconductive Interference Screw is commonly known as the Calaxo® Bone Screw and used in knee surgeries. Specifically, these are used in ACL (Anterior Cruciate Ligament) reconstruction and are a replacement for the metal screws that were previously used. Manufactured by Smith & Nephew, Calaxo® is a  bio-absorbable polymer and calcium device. When it was first marketed, many hailed this innovation, little knowing that it could bring side effects with far-reaching consequences.
 
Calaxo® Side Effects
Calaxo® bone screws can create many painful complications for patients. The side effects that these can cause are fever, redness, swelling, fluid build-up, infection and increasing levels of pain at the incision site. Many patients have reported local soft tissue swelling in the tibial area. The worst side effect that has been noticed is that these screws have broken into fragments inside the body and caused excruciating pain. In some cases, patients have had to have them surgically removed. The usual time frame that these side effects have been observed is between 2 and 36 weeks after the ACL reconstructive surgery.
 
FDA & Calaxo®
The FDA approved the Calaxo® screw and it came into usage in March 2006. Almost immediately, there was an alarming increase in reports of complications arising from the use of Calaxo® bone screws. At this, the FDA reacted and issued a recall in August 2007.
 
Calaxo® & The Law
If you or someone you know has been injured due to the usage of the Calaxo® screw, you may have legal rights that entitle you to compensation.
Contact Eric W. Gruenwald, Attorney / Lawyer for more information at 866-529-0001 Extension 245.

Calaxo Screw Recall: If you or a loved one have a Calaxo® Bone Screw, please contact us immediately.

May 2009

Anyone who may have received a Calaxo® Bone Screw should contact us immediately.  Even if you are not currently experiencing any discomfort, etc., you may still have a claim.  Please review the dates and other details of the recall on our article on Calaxo located at http://www.mulliganlaw.com

CALAXO SCREW RECALL UPDATE

April 2009

Perhaps you are having pain or other difficulties after having the Calaxo Screw involved with your ACL surgery? 

The United Kingdom issued an immediate recall of all CALAXO Osteoconducive Interference Screws employed in Anterior Cruciate Ligament (ACL) surgery.  This recall took place in August 2007.  The recall affets all lot numbers and all item codes for CALAXO Screws put into the market since 2006.  The device was approved in 2006. 

The Calaxo Screw is manufactured by the Endoscopy division of Smith & Nephew. 

ANYONE who suspects they had a Calaxo screw installed during surgery should contact us immediately.  Even if you are currently not experiencing any difficulties, you may still have a claim if you have a Calaxo Screw. 

It is still unclear if the recall issued in the United Kingdom will be followed by a similar recall in the United States. 

Patients who suffer from side effects due to the Calaxo Screw may require additional surgery. 

If you experience any Calaxo injury symptoms, you should promptly discuss these issues with your physician. 

The Texas, Florida, & California Attorneys of The Mulligan Law Firm are now evaluating Nationwide potential claims related to the CALAXO screw.  Lawyers are standing by ready to speak with you or your loved ones concerning your potential claim.  Please submit your information on this website or email us at help@mulliganlaw.com as soon as possible.  It is important not to delay as important time deadlines and statute of limitations issues may otherwise completely bar your potential claim and you can then lose all your legal rights.