The product was not returned with the packaging, so the complaint cannot be verified, but is likely based on the packaging configuration.The packaging configuration was changed to the standard hip stem configuration that prevents product movement within the packaging and did not encounter adhesive flaking during the packaging performance validation.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to packaging control : package damaged during shipment.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.(b)(4).
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