Zimmer Biomet has issued a Class I recall for its Comprehensive Reverse Shoulder as the devices have exhibited higher rates of fracturing than previously stated.
In December 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice to customers who may have undergone surgery in which a Comprehensive Reverse Shoulder was implanted. This recall has been classified as a Class I recall by the Food and Drug Administration (FDA), as the use of the affected devices has the capacity to cause serious injury.
What is a Comprehensive Reverse Shoulder?
The Comprehensive Reverse Shoulder is a replacement implant that is intended to restore a full range of motion in a patient’s arm. Such devices have typically been used for patients suffering from failed shoulder joint replacement and rotator cuff tears.
Why is Zimmer Biomet Recalling the Device?
Comprehensive Reverse Shoulder implants have exhibited higher rates of fracture than Zimmer Biomet had previously stated on product labels. Such fractures can cause a number of problems, requiring a patient to undergo revision surgery. Being so, patients who have received the Comprehensive Reverse Shoulder are at risk of adverse health consequences such as infection, permanent shoulder damage, loss of shoulder function and, in severe cases, death.
What Can I Do if I have Received a Reverse Shoulder Implant?
Medical providers who have performed shoulder replacement surgery using the affected Zimmer Biomet Comprehensive Reverse Shoulder should have received an Urgent Medical Device Recall Notice from the manufacturer. This notice has advised recipients to follow specific instructions for removing affected implants from stock. However, the notice did not specify or recommend any procedures for monitoring patients beyond normal surgical follow-ups.
If you have undergone total shoulder replacement surgery after suffering from a failed shoulder joint replacement, arthropathy or rotator cuff tears, and may have received a Comprehensive Reverse Shoulder implant during your surgery, you should contact your physician to have the device examined.