(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 and corrected information.The following section has been updated: b4, e1, e2, e3, g4, g7, h2, h3, h6 and h10.The following section has been corrected: b3, b5.Received pictures show the patient labels: the ref/batch combination of the product involved in the complaint can be confirmed.Also,pictures of the optipac show that the cement has been mixed, the plunger is up, the mixing rod broken and the nozzle assembled.The paste seems homogeneous, no alter consistency can be seen.However, the cement paste seems to be white (and not green) which could indicate that the mixing was not completed.Also, it can be observed some empty space in the cylinder, which means that the cement was not pressurized enough.Indeed, the plunger is not up enough.The product analysis can't be performed as the product was not returned.A retain sample of batch az05dk0806 has been tested in the laboratory under standardized conditions (23°c; rel.Humid >=40 %).No unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding cement paste consistency: 1 complaint (1 product, this one included, has been recorded on optipac 80 refobacin bone cement r-3, reference (b)(4), from (b)(6) 2017 to (b)(6) 2021.1 complaint (1 product), this one included, has been recorded on optipac 80 refobacin bone cement r-3, reference (b)(4), batch az05dk0806.According to available data, root cause of the event was unable to be determined.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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