Trunnion Failure of the Recalled Low Friction Ion Treatment Cobalt Chromium Alloy Femoral Head.

BACKGROUND: Gross trunnion failure (GTF) is a rare complication in total hip arthroplasty (THA) reported across a range of manufacturers. Specific lots of the Stryker low friction ion treatment (LFIT) anatomic cobalt chromium alloy (CoCr) V40 femoral head were recalled in August 2016. In part, the recall was based out of concerns for disassociation of the femoral head from the stem and GTF. METHODS: We report on 28 patients (30 implants) with either GTF (n = 18) or head-neck taper corrosion (n = 12) of the LFIT CoCr femoral head and the Accolade titanium-molybdenum-zirconium-iron alloy femoral stems. All these cases were associated with adverse local tissue reactions requiring revision of the THA. RESULTS: In our series, a conservative estimate of the incidence of failure was 4.7% (n = 636 total implanted) at 8.0 ± 1.4 years from the index procedure. Failures were associated with a high-offset 127° femoral stem neck angle and increased neck lengths; 43.3% (13 of 30) of the observed failures included implant sizes outside the voluntary recall (27.8% [5 of 18] of the GTF and 75.0% [8 of 12] of the taper corrosion cases). Serum cobalt and chromium levels were elevated (cobalt: 8.4 ± 7.0 µg/mL; chromium: 3.4 ± 3.3 µ/L; cobalt/chromium ratio: 3.7). The metal artifact reduction sequence magnetic resonance imaging demonstrated large cystic fluid collections typical with adverse local tissue reactions. During revision, a pseudotumor was observed in all cases. Pathology suggested a chronic inflammatory response. Impending GTF could be diagnosed based on aspiration of black synovial fluid and an oblique femoral head as compared with the neck taper on radiographs. CONCLUSION: In our series of the recalled LFIT CoCr femoral head, the risk of impending GTF or head-neck taper corrosion should be considered as a potential diagnosis in a painful LFIT femoral head and Accolade titanium-molybdenum-zirconium-iron alloy THA with unknown etiology. Almost half of the failures we observed included sizes outside of the voluntary recall.