This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 correction: h4 complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows has fractured on the posterior side.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A root cause can be determined as normal wear during the instrument¿s field life.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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