(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-04892, 0001822565-2017-06259.(b)(4).Complaint sample was evaluated and the reported event was confirmed.The received outer pouch is only sealed on one end and doesn't appear to have ever been sealed.Root cause can be attributed to inadequate sealing of the pouch during the packaging process.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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