(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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It has been reported that, during the surgery, the polymer was leaking from the inner pouch because a part of the inner polymer pouch was unsealed.As reported, the surgery was finished with backup product.No adverse event has been reported as a result of the malfunction.
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(b)(4).This follow-up report is being submitted to relay additional information.No further information provided (x-rays, surgical report, photographs, lab test).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 lot number) 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: - to date (15-oct-2021) 13 complaints (involving 13 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, since ever.- 5 complaints (involving 5 products), this one included, have been recorded on biomet bone cement r 1x40 jp, reference 110035372, batch z35aaf1509, since ever.To date, no root cause could be determined for the reported packaging issue, however as a trend was identified, a capa 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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It has been reported that, during the surgery, the polymer was leaking from the inner pouch because a part of the inner polymer pouch was unsealed.As reported, the surgery was finished with backup product.No adverse event has been reported as a result of the malfunction.
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