A new study suggests that patients who undergo metal allergy screening prior to surgery may be less likely to experience shoulder replacement failure.
To asses the impact of metal allergy on patient outcomes, the authors of the Orthopedics study conducted a retrospective chart review of individuals who had undergone shoulder replacement from January 1, 2012, to January 31, 2015.
Case characteristics collected included patient risk factors (age, sex, prior cutaneous reactions to metal), metal allergy factors (type of metal allergy, method of diagnosis), and surgery factors (implant type, primary/revision, type of shoulder arthroplasty). Outcomes were measured via the American Shoulder and Elbow Surgeons score, Penn Shoulder Score, and Single Assessment Numeric Evaluation score.
A total of 11 patients were identified with metal allergy. Five were diagnosed prior to their shoulder replacement, while 6 were diagnosed post-surgery. Those diagnosed after implantation presented with progressive pain and stiffness, but none had cutaneous manifestations.
“Metal allergy is a rare but potentially clinically relevant cause of unsatisfactory shoulder arthroplasty,” the paper concludes. “Based on the authors’ experience, metal allergy remains a diagnosis of exclusion after other, more common causes of failed shoulder arthroplasty have been ruled out. Both skin patch testing and MELISA testing can be used to determine the presence of metal hypersensitivity; however, the clinical implications of a positive test result still need to be defined.”
Zimmer Biomet Shoulder Replacement Recall
Publication of this study comes nearly one year after the U.S. Food & Drug Administration (FDA) announced a Zimmer Biomet Comprehensive Reverse Shoulder replacement recall involving more than 3,660 Humeral Trays (Model 115340) that had been associated with a higher-than –anticipated rate of fracture. The agency designated the action a Class I medical device recall, after determining that the affected 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 shoulder implants named in the lawsuit were included in a September 2010 that was also prompted by a high fracture rate. The FDA designated that recall Class II, which indicates that a medical device can cause temporary or medically reversible complications. (Case No. 1:14-cv-02667-REB-NYW)