This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d1, d2, d9, g1, g3, g6, h1, h2, h3, h6, h11.Review of the device history record identified no deviations or anomalies during manufacturing.Device was 34 months old and is not out of box failure.The device was not returned.A definitive root cause cannot be determined.If any further information is found 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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