Do you or someone you know have a Comprehensive Reverse Shoulder surgically implanted to help restore arm movement?
When Zimmer Biomet unveiled their Zimmer Biomet’s Comprehensive® Reverse Shoulder System, it promised to restore function to a patient’s shoulder one patient at a time. The system was meant to offer unmatched intraoperative flexibility and revolutionize the current shoulder systems on the market and minimize the potential challenges of removing a well-fixed humeral stem by allowing conversion to a reverse shoulder using any of the existing Comprehensive Shoulder Stems.
The FDA has just issued a recall as these devices are fracturing at a rate higher than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Whilst this shoulder replacement device is beneficial for patients with rotator cuff tears who have developed arthropahy – a severe type of shoulder arthritis, patients fitted with this device must take extra precaution due to the higher rate of fracture occurring.
What do you have to do next?
On the 20th of December 2016, Zimmer Biomet, the manufacturer of the implant sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice requested for the customers to:
- review the safety notice and ensure appropriate staff is aware of the notice;
- identify and quarantine any affected devices in stock;
- the Zimmer Biomet sales representative will remove the affected device from the facility;
- complete and return the Certificate of Acknowledgement form within 3-days via e-mail to [email protected]; and
- retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.
Zimmer Biomet stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.
The FDA is encouraging all health care professionals and patients to report any adverse events or side effects related to the use of the Comprehensive Reverse Shoulder to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-3321088.
Have you or someone you know used the Comprehensive Reverse Shoulder manufactured by Zimmer Biomet? Get in touch with us at [email protected] to tell us about your experience!
Read the full FDA alert here.