(b)(4).Report source, foreign - event occurred in (b)(6).Pictures have been received.The reported event was confirmed as it can be seen that the inner cement pouch sealing is damaged and that cement powder leaked outside the inner pouch.The product analysis can't be performed as the product was not returned.The complaint is related to a well-known event, previously evaluated and investigated.No further investigation is required as per 21 cfr part 820.198 complaint files §(b) and (c).Investigation results concluded that the reported event was due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.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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It has been reported that, before the surgery, it was found that the powder of the inner package leaked out.As reported, the product will not be returned due to the cost of shipment.No adverse event has been reported as a result of the malfunction.
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