Tag Archive | adverse local tissue reaction

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.”

Metal-on-Metal Hip Arthroplasty: Where Do We Go From Here?

OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Richard S. Yoon, MD.

We’re entering the “midterm” follow-up period for the metal-on-metal (MoM) hip devices implanted in the early 2000s, and recent reports from around the world are confirming early concerns. Several studies published during the first few months of 2016 report unacceptably high failure rates.

In the Open Orthopaedics Journal, Mogensen et al. reported an 18.4% revision rate in more than 100 CONSERVE MoM hips, at a mean follow-up of 4.5 years. These results led the Danish authors to terminate the use of MoM at their centers.

In the BMJ Open, Langton et al. reported a 16% failure rate among more than 350 Pinnacle MoM hips after about nine years of follow-up. Greiner et al. published a follow-up of prior research in a recent edition of the Journal of Arthroplasty. Among more than 150 MoM modular acetabular components with 5- to 12-year follow-ups, the results related to adverse local tissue reactions and revisions were inferior when compared with those of metal-on-polyethylene articulations. Dhotare et al., in Hip International, reported an alarming failure-rate increase from 7% at six years to 29% at ten years for the Birmingham MoM cup and large metal head.

While we cannot turn back the clock on the past use of MoM devices, we have some information about surveillance and treatment that may help us prevent catastrophic failure.

Data regarding the effects of increasing serum metal ions are mixed. Some studies have found a direct correlation between high metal ion levels and the incidence of adverse tissue reactions (and the need for subsequent revision), while other studies have not.  A recent JBJS study identified cobalt-ion thresholds that could help stratify patients with Birmingham and Corail-Pinnacle hips who are at low risk of metal-debris adverse reactions.

The systemic effects of increased serum metal ions are also being debated. Some case reports have cited neurotoxicity presenting as tinnitus, gait imbalance, and other issues, while a more recent, larger longitudinal study published in the Journal of Arthroplasty did not confirm this correlation. Those authors surmised that increased serum ion levels may cause neurotoxicity-associated symptoms primarily in MoM patients with metal hypersensitivity.

Metal artifact reduction sequence (MARS) MRI has been helpful in early identification of adverse soft tissue reactions. However, there is no general consensus or guideline as to when and how often this technology should be utilized in order to provide consistent surveillance and/or indications for revision.

While we are still trying to understand the finer points of the many variables related to MoM, there is an obvious need to forge consensus. Recently, in the Bone and Joint Journal, Berber et al., representing the International Specialist Centre Collaboration on MoM Hips (ISCCoMH), conducted a survey among six international tertiary referral centers to assess the overall consensus in surveillance and treatment practices. Only a moderate agreement value (kappa = 0.6) was found. This inconsistent agreement led the group to call for international coordination to help set forth guidelines that would standardize and improve surveillance of and treatment for those with MoM hips.

Richard S Yoon, MD is executive chief resident at the NYU Hospital for Joint Diseases.