As reported, approximately 15 months postop, this male (b)(6) thin, healthy male, fractured his r ankle cage 15 months postop and was revised.No other information is available at this time.
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Section h10: d6b: (b)(6) 2021.H3: the revision reported may have been the result of an insufficient bond between the tibial component and the bone, which led to aseptic (non-infected) tibial loosening and ultimately resulted in the fracturing of the center cage.However, this cannot be confirmed as device was not available for evaluation.
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