This follow-up report is being submitted to relay additional information.No product was returned provided; visual and dimensional evaluations could not be performed.However, pictures of the explanted product was provided.It was identified the bushing was fractured.Black debris was visible on the components likely consistent with metallosis.Bio debris was affixed to the stem.The bushing pin fracture cannot be identified from the picture provided.The reported products were reviewed for compatibility with no issues noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic lucencies in the distal humerus, which is nonspecific and can represent loosening, but also can be seen in the setting of metallosis.There is angulation of the distal tip of the pin, which is nonspecific and cannot be fully evaluated based upon the provided radiograph image dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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