(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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(b)(4).This follow-up report is being submitted to relay additional information.Two pictures were received showing that the sealing of the inner pouch is damaged, which confirmed the reported event.The product was returned and lab analysis was performed.The product analysis shows that the product has been returned in original box with just the aluminum and inner pouches.The aluminum pouch is not damaged.On the inner pouch, there is a hole on one corner that allows the cement powder to leak.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A sealing force test has been performed on a product received from a similar complaint (same item reference) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.A complaint extract was done regarding inner cement pouch open sealing: - 19 complaints (19 products), this one included, have been recorded on biomet bone cement 1x40 jp, reference 110035372, to date (november 17, 2021).- 14 complaints (14 products), this one included, have been recorded on biomet bone cement 1x40 jp, reference 110035372, batch z34eaf1509, to date (november 17, 2021).According to available data, root cause of the event was unable to be determined.However, an action has been initiated in order to deeper investigate the cause of the event with the cement pouch supplier osartis and to consider to implement actions to avoid the recurrence of this type of 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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