The incidence of adverse local tissue reaction due to head taper corrosion after total hip arthroplasty using V40 taper and 36 mm CoCr head

Abstract

Aims Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors. Methods Between January 2006 and June 2007, a total of 121 patients underwent THA using either an uncemented (Accolade I, made of Ti12Mo6Zr2Fe; Stryker, USA) or a cemented (ABG II, made of cobalt-chrome-molybdenum (CoCrMo); Stryker) femoral component, both with a V40 taper (Stryker). Uncemented acetabular components (Trident; Stryker) with crosslinked polyethylene liners and CoCr femoral heads of 36 mm diameter were used in all patients. At a mean folllow-up of 10.8 years (SD 1.1), 94 patients (79%) were eligible for follow-up (six patients had already undergone a revision, 15 had died, and six were lost to follow-up). A total of 85 THAs in 80 patients (mean age 61 years (24 to 75); 47 (56%) were female) underwent clinical and radiological evaluation, including the measurement of whole blood levels of cobalt and chrome. Metal artifact reduction sequence MRI scans of the hip were performed in 71 patients. Results A total of 20 ALTRs were identified on MRI, with an incidence of 26%. Patients with ALTR had significantly higher median Co levels compared with those without ALTR (2.96 μg/l (interquartile range (IQR) 1.35 to 4.98) vs 1.44 μg/l (IQR 0.79 to 2.5); p = 0.019). Radiological evidence of osteolysis was also significantly associated with ALTR (p = 0.014). Median Cr levels were not significantly higher in those with ALTR compared with those without one (0.97 μg/l (IQR 0.72 to 1.9) v 0.67 μg/l (IQR 0.5 to 1.19; p = 0.080). BMI, sex, age, type of femoral component, head length, the inclination of the acetabular component, and heterotopic ossification formation showed no significant relationship with ALTR. Conclusion Due to the high incidence of local ALTR in our cohort after more than ten years postoperatively, we recommend regular follow-up investigation even in asymptomatic patients with V40 taper and metal heads. As cobalt levels correlate with ALTR occurrence, routine metal ion screening and consecutive MRI investigation upon elevation could be discussed. Cite this article: Bone Joint J 2022;104-B(7):852–858.

The impact of the European Union’s Medical Device Regulation on orthopaedic implants, technology, and future innovation

“…5 Moreover, adverse events had been reported with medical devices across several specialties, including pelvic floor mesh repair in gynaecology, prosthetic implants in breast surgery, and metalon-metal hip components in orthopaedics. [6][7][8][9][10][11][12] After a transition period of four years, including a one-year postponement due to the COVID-19 pandemic, the EUMDR became fully binding and applicable in May 2021. This article discusses the pertinent points of the EUMDR in relation to orthopaedic medical devices, and explores how this new regulation affects patient safety, technological advances, and future innovation capacity in orthopaedics.…”