FDA White Paper Cites JBJS “Case Connections” Article
There are 15 references to JBJS studies in the recently published 149-page white paper on “Biological Responses to Metal Implants,” from the FDA’s Center for Devices and Radiological Health. Most of those references are made in Section 7.5.1 (pp. 54-57), which focuses on orthopaedic devices.
The plethora of JBJS references is not surprising, but we were happy also to see that a JBJS “Case Connections” article was cited twice in the white paper. While most of the section on orthopaedic devices discussed metal-on-metal (MoM) hip problems, the FDA noted that adverse biological responses to metals in orthopaedics sometimes occur in the upper extremity. It did so by citing “Adverse Local Tissue Reactions in the Upper Extremity,” which appeared in the May 24, 2017 issue of JBJS Case Connector. The FDA white paper cautioned that metal wear debris-related adverse reactions have occurred with shoulder suture anchors (five cases of which are described in the “Case Connections” article) and with intramedullary humeral nailing (one case of which is described in the “Case Connections” article).
Among the take-home points made by co-authors Thomas Bauer and Allan Harper in the cited “Case Connections” article is this: “Patients with shoulder suture anchors who develop delayed-onset pain and/or stiffness, osteolysis, chondrolysis, or early arthropathy should be evaluated and consideration should be given to the removal of loose or prominent anchors to lessen the risk of articular damage.”