This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d10, g3, g6, h1, h2, h3, h6, h10. visual examination of the returned product identified the product as broken with nicks and gouges.The device history records for the item were reviewed, and identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.The complaint was confirmed.A definitive root cause cannot be determined.No corrective/preventive actions needed at this time.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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