Zimmer Biomet Comprehensive Reverse Shoulder Replacement Recall
Every year, thousands of people in the United States undergo shoulder replacements to fix a variety of shoulder issues. Pain, loss of mobility, damage caused by arthritis, shoulder joint fracture, severe dislocation, rotator cuff tears and other illnesses and injuries can often be fixed by shoulder replacement surgeries.
There are two main types of surgery: total shoulder replacement and reverse total shoulder replacement procedures. These replacements help to restore arm movement and function following an injury. They also mimic the shoulder anatomy, with a cup, ball and socket components.
Unfortunately, these shoulder replacements do not always work as intended. Patients choose to undergo shoulder replacement surgery to improve mobility and to alleviate pain. However, many patients who have opted to have shoulder replacement surgery have reported numerous complaints, including pain and/or need for device removal.
Why Was The Zimmer Biomet Shoulder Implant Recalled?
Zimmer Biomet, is one of the latest medical device companies to recall a Shoulder Replacement System. The company recalled its Comprehensive Reverse Shoulder in December 2016 after it was discovered that the device was fracturing at high rates – rates much higher than what was indicated on the product’s packaging and labeling.
The Food and Drug Administration (FDA) has classified the Zimmer Biomet Comprehensive Reverse Shoulder recall as a Class I recall. A Class I recall is the most serious recall, which means the shoulder replacement can lead to serious injury or even death. No deaths have been reported, but the FDA has received numerous complaints of pain, malfunction and need for revision surgery from patients with the device.
What Zimmer Biomet Shoulder Replacement System Has Been Recalled?
The recalled product is the Comprehensive Reverse Shoulder System Humeral Tray Model 115340. All lots with part number 115340 are affected. In total, 3,662 devices are subject to the recall. You can view a complete list of the affected lot numbers here.
The product codes are KWS and PAO. The devices were manufactured from August 25, 2008 to September 27, 2011 and distributed between October 2008 and September 2015.
How Do I Find Out If My Shoulder Replacement System Was Recalled?
If your shoulder replacement system was part of the recall, you should have received in the mail an Urgent Medical Device Recall Notice. Zimmer Biomet sent out these notices to affected patients on December 20, 2016. If you did not receive this notice and you believe that you may have a recalled device, it is recommended that you contact the surgeon who implanted the device and/or the facility were the device implant procedure was performed.
As far as patient monitoring goes, healthcare providers were given no specific instructions. Regular post-surgical follow-up was recommended. Patients with recalled devices should follow up with their doctor as usual, especially if they notice any of the following symptoms which can indicate device fracture or another serious issue:
- Shoulder stiffness
- Shoulder weakness
- Clicking sounds in the shoulder area
- Device Loosening
- Restricted range of motion in shoulder
- Sudden pain in the shoulder area
Zimmer Biomet Reverse Shoulder Replacement Complications
Shoulder replacements suffer from wear and tear over time. It is not unusual for them to break down or even fracture after many years of frequent use. However, Zimmer Biomet Comprehensive Reverse Shoulder Replacement System patients have reported an unusually high rate of early device fracture issues. If a fracture occurs, immediate medical treatment is crucial. A shoulder fracture can affect the entire body and even cause abdominal, cardiac and pulmonary complications.
If the shoulder replacement device fractures, a patient must undergo revision surgery. The reported rate of revision surgery for the Zimmer Biomet Comprehensive Reverse Shoulder device is also unusually high as compared to other reverse shoulder replacement systems. Revision surgery is a major procedure that is very costly and is associated with a lengthy recovery process. The revision procedure carries its own risks including permanent loss of shoulder function, major bleeding, infection and even death.
Previous Issues with Zimmer Orthopedic Devices
The Comprehensive Reverse Shoulder recall is not the first recall for Zimmer Biomet medical device products. In 2008, the Zimmer Durom Hip Device was recalled due to a faulty design. Like the Reverse Shoulder System, the hip device was associated with a high rate of revision procedures to remove and replace the device.
In 2010, Zimmer issued a Class II Recall of its Zimmer NexGen Knee Replacement System. In 2012, the FDA issued a Class II Device Recall of the Zimmer Trilogy Hip System. The Zimmer Proxilock Hip Prothesis has also shown a high rate of femoral fractures, but no recall has been issued to date. In 2015, Zimmer recalled nearly 12,000 units of its Zimmer Persona Knee Implant components due to reports of high failure rate and need for revision surgery.
Zimmer Biomet Shoulder Replacement Lawsuit
The Zimmer Shoulder Replacement Lawsuit Attorneys of Nadrich & Cohen, LLP and their partners have previously represented thousands of defective hip and knee replacement victims. We have taken on the biggest medical device manufacturers in the world, including Zimmer, Biomet, Wright, DePuy, Stryker and more.
Our lawyers are actively investigating and pursuing claims on behalf of patients who were implanted with a Zimmer Biomet Comprehensive Reverse Shoulder Replacement System and were advised that a revision surgery was needed.
If you or a loved one has a Zimmer Biomet Comprehensive Reverse Shoulder Replacement System and you have been told that you will require a revision procedure, or you have undergone a revision procedure, contact our law firm now for a free and confidential consultation. Call us at 1-800-718-4658.
Don’t wait as there are strict time limitations for making a claim. Call us now.