A recently published study suggests that shoulder replacement patients are more likely to require revision surgery if they are obese. The research, which appeared in the June 7th issue of The Journal of Bone & Joint Surgery, also indicated that a higher body mass index (BMI) increases the risk of shoulder implant loosening and other mechanical failures.
The study drew data from 4,567 shoulder replacement surgeries performed between 1970 and 2013. Forty-three percent of the patients were obese (BMI of 30 or higher). Overall, 302 required revision surgery due to mechanical failure and other causes, while 62 suffered complication that required a non-revision operation.
Obese patients were more likely to require a revision or non-revision surgery. Each one-unit increase in BMI over 30 corresponded to a 5 percent increase in the overall risk for revision, while a high BMI was also specifically associated with a higher likelihood of revision due to mechanical failure. The risk of wound infections grew by 9 percent for each 1 unit increase in BMI.
The odds of BMI-related shoulder replacement complications remained high even after the research team adjusted for other factors.
“Increasing BMI is strongly associated with increased rates of revision surgical procedures and postoperative complications after shoulder arthroplasty,” the study authors concluded. “It is important to consider these findings when counseling patients, estimating risks, and estimating complication risks
Publication of this study comes just three months after the U.S. Food & Drug Administration (FDA) announced a Zimmer Biomet Comprehensive Reverse Shoulder replacement recall. According to the agency, the 3,662 Comprehensive Reverse Shoulder Humeral Trays (Model 115340) included in the Class I recall had been associated with a higher-than –anticipated rate of fracture. Class I recalls are the FDA’s most serious category of recall, and indicate that a device poses a risk of serious injury or death.
Last February, Biomet agreed to pay $350,000 to settle a shoulder replacement lawsuit filed on behalf of a Colorado man who had suffered fractures of two Comprehensive Reverse Shoulders implants. The same shoulder replacements were recalled in September 2010 due to a high fracture rate. The FDA designated the recall Class II, which indicates that a medical device can cause temporary or medically reversible complications. (Case No. 1:14-cv-02667-REB-NYW)