Reverse Shoulder Implant Side Effects
The labeling for the Biomet reverse shoulder system carries a list of contraindications. Contraindications are instances or situations under which a treatment should not be used because it could prove harmful to the patient.
Both absolute, as well as relative contraindications are listed for the reverse shoulder system. Relative contraindications indicate that caution should be taken when using a particular treatment in combination with the listed factor, while absolute contraindications are more severe and indicate the potential for a life-threatening situation to occur.
Absolute contraindications listed for the Biomet reverse shoulder system include infection, sepsis and osteomyelitis.
Relative contraindications include: Uncooperative patient, or patient with neurologic disorders who is incapable or unwilling to follow directions; Osteoporosis; Metabolic disorders, which may impair bone formation; Osteomalacia; Distant foci of infections which may spread to the implant site; Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Recalls of Zimmer Biomet Comprehensive Reverse Shoulder Implant
In mid-December 2016, Zimmer Biomet initiated a recall of its Comprehensive Reverse Shoulder. Before the end of the year, the manufacturer had sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice requested that any devices still in stock be identified, quarantined and returned.
Apparently, the medical devices were, according to the FDA, “fracturing at a higher rate than is stated in the labeling.” Fractures could require a patient to undergo revision surgeries, which the agency determined could “cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
In February 2017, the FDA issued a recall for the Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340. The agency identified the issue as a Class I recall, which indicates use of the device could lead to death or serious injury.
The manufacturer, in its recall notice, stated that there were no specific monitoring instructions for patients using the affected devices beyond existing surgical follow-up protocol.
The 2017 recall involves 3,662 medical devices. The devices were manufactured from August 2008 to September 2011, and distributed from October 2008 to September 2015. The recall targets devices bearing product codes KWS or PAO, and lot number 115340.
Though this recall is the only Class I event, it isn’t the first time Zimmer Biomet reverse shoulder products have faced a recall. In 2010, the device was recalled after the manufacturer received complaints regarding fracturing of the device. In 2011, the device was again the target of a recall, this time due to an “employee error” and the “rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.”