Zimmer Biomet Shoulder Implant

 

Zimmer Biomet Shoulder Injury Lawsuit

Please note: At this time, the dangerous drug attorneys at Searcy Denney are not accepting cases for injuries from the Zimmer Biomet Shoulder device. If you or a loved one has suffered injuries by another dangerous drug or medical device, we are always available to answer your legal questions for free.

When having a surgery makes an injury worse, it’s hard to imagine what your options are after that. This is the case for many who have undergone a shoulder surgery within in recent years. If you suffered complications after receiving a Zimmer Biomet implant during your shoulder operation, you are not alone.

The shoulder implant, known as a Comprehensive Reverse Shoulder device, is manufactured by Zimmer Biomet. In early 2017, the FDA issued an urgent recall on the product for adverse side effects associated with revision surgery.

 

What Is a Zimmer Shoulder?

zimmer-biomet-shoulder-implant
The Zimmer Biomet Shoulder implant is an anatomical medical device that simulates the humerus bone and socket of the shoulder, originally created to help restore an individual’s arm movement. After it’s surgically implanted, the tool reverses the normal anatomy of the shoulder, as the ball is placed on the shoulder blade and socket of the upper arm, allowing the deltoid muscle to control the entire arm.

Though reverse total shoulder replacement surgery is generally known for its complexity as well as its complications, thousands are still performed annually throughout the U.S.. Zimmer Biomet claimed their product was especially beneficial for those suffering from a rotator cuff tear, which often leads to the development of arthritis, or “cuff tear arthropathy.” Patients whose previous shoulder replacement surgeries were unsuccessful also qualified for and received the Zimmer shoulder implant.

As the second-largest medical device manufacturer in the world, Zimmer Biomet sells more than one million artificial knee, shoulder, hip, ankle, foot and elbow implants annually. The company sees more than $4.5 billion sales each year.

Zimmer Biomet manufactured the device between August 2008 and September 2011, before distributing it between October 2008 and September 2015. This means that if you received comprehensive reverse shoulder implant surgery during that time, you may have been implanted with a defective device.

Zimmer Biomet Shoulder Recall

Earlier this year, the FDA issued an urgent recall on the Zimmer Biomet Comprehensive Reverse Shoulder implant. The recall is a “Class 1” recall, which is the highest recall level possible and indicates there’s a “reasonable probability that use of these products will cause serious adverse health consequences or death.”

The FDA released the following information regarding the product. This is pertinent information for any patient who thinks they might have a defective shoulder implant:

Class 1 Recall

Product Description:
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Trade Name:
Biomet Comprehensive Reverse Shoulder Humeral
Product Code:
KWS, PAO
Lot Numbers:
All lots with part number 115340
Distribution Dates:
October 2008 to September 2015
Manufacturing Dates:
Aug 25, 2008 to Sep 27, 2011
Devices Recalled:
3662

Risk of Injury with Zimmer Shoulder

Patients who received the Zimmer Biomet Comprehensive Reverse Shoulder device between October 2008 and September 2015 are at risk for injury. If you or a loved one underwent a reverse shoulder replacement surgery or total shoulder replacement surgery during the aforementioned dates, you should contact your healthcare provider to see which product was used in your operation.

Risks associated with the Zimmer Biomet Comprehensive Reverse shoulder implant include permanent loss of shoulder function, infection and, in rare yet worse case scenarios, death.

It’s important that you check with your physician as soon as possible, even if you aren’t experiencing adverse symptoms or side effects following your shoulder surgery.

Reasons Behind the Zimmer Shoulder Recall

The problem with the Zimmer Biomet device is in its design, versus a manufacturing error. The device has a high rate of fracturing, more so than what is stated on the product’s label. When this happens, the patient usually has to have a revision surgery. This puts them at a higher risk for permanent loss of shoulder function, pain and infection, which can ultimately result in irreversible harm such as death.

 

Next Steps for Zimmer Shoulder Implant Recipients

zimmer biomet shoulder replacement lawsuit attorneys
Were you implanted with a Zimmer Biomet Comprehensive Reverse Shoulder device? If so, contact your physician – even if you haven’t experienced adverse side effects or any other symptoms. Your health could be at stake.

If you received a shoulder implant but are unsure as to what type or model it was, contact the hospital where you had your surgery. You are entitled to copies of your medical records, which should reveal whether you received the Zimmer Biomet implant and if qualify for the Zimmer Shoulder replacement lawsuit.

If you have already experienced issues or complications with your shoulder implant, you can report them directly to the FDA MedWatch.

 

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