(b)(4).Morrey me, songy c, triplet jj, cheema an, o¿driscoll sw, sanchez, sotelo j, morrey bf, unexpected high early failure rate of the nexel total elbow arthroplasty, jses international (2022), doi: https://doi.Org/10.1016/j.Jseint.2022.04.001.Component code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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