Cmp- (b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicates that the released product met all requirements to perform as intended.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.Four pictures were received and the reported event has been confirmed.In addition, the involved product was returned and analyzed: the inner cement pouch sealing was opened and damaged.Thus, the reported event has been confirmed.A sealing force test has been performed on a product received from a similar complaint ((b)(4)- same item reference) and showed that the pouch sealing force a was compliant with zimmer biomet valence specification.A complaint extract was done regarding packaging : inner pouch_open sealing: 4 complaints (involving 4 products), this one included, have been recorded regarding the brand cement pack (e) (sp) bbcr to date 22-apr-2021, and since ever.2 complaints (involving 2 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, batch z34eaf1509, since ever.To date, no root cause could be determined for the reported packaging issue, however as a trend was identified, a global investigation has been initiated in order to implement actions to avoid the recurrence of this type of issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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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