Background and purpose - We noted several adverse events in patients in whom the first version of the STRYDE limb-lengthening nail (NuVasive Specialized Orthopaedics, San Diego, CA) had been implanted. Pain, osteolysis, periosteal reactions, and cortical hypertrophy at the nail junction were noted. Here, we present the analysis of 23 retrieved STRYDE implants.Materials and methods - We undertook visual inspection of the retrieved nails and screws, mechanical evaluation of the junction, micro-CT analyses, microscopic inspection of the bushing, screws, screw holes, and separated parts of the implants. Positive material identification (PMI) and energy-dispersive X-ray spectroscopy (EDS) were used to analyze the chemical composition. The hardness of the material was also investigated.Results - 20/23 retrieved nails had visible signs of corrosion, i.e., discoloration at the telescopic junction. Micro-CT verified corrosion attacks in 12/12 scanned bushings. Corrosion, predominantly mechanically assisted crevice corrosion, was observed at the locking screws and screw holes in 20/23 nails. Biological material inside the nail was observed in addition to oozing from the junction of 2 nails during hardware removal, which was experimentally reproducible. Notably, the mechanical construction of the bushing changed from PRECICE P2 to STRYDE nails.Interpretation - STRYDE nails are not hermetically sealed, and liquid can pass the bushing. Biodur 108 itself is corrosion resistant; however, mechanically assisted crevice corrosion of the bushing, locking screws, and screw holes may be aggravated due to manufacturing aiming for increased strength and hardness of the alloy.Observing several adverse events, we recently published a nationwide cross-sectional analysis of all 30 STRYDE limb- lengthening nails (NuVasive, Specialized Orthopedics, San Diego, CA) that were implanted in Denmark (Rölfing et al. 2021a). 27/30 STRYDE nails have now been removed and we present data from metallurgical analysis of 23 of the retrieved implants.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8519523 | PMC |
| http://dx.doi.org/10.1080/17453674.2021.1927506 | DOI Listing |
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