(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore it will not be analyzed.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).The product analysis can't be performed as the product was not returned.A retain sample of batch a927a02665 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 too short setting time: - 4 complaints (7 products), this one included, have been recorded on optipac 60 refobacin plus bone cement-3, reference (b)(4) -3, from (b)(6) 2020.- 2 complaints (4 products), this one included, have been recorded on optipac 60 refobacin plus bone cement-3, reference (b)(4) -3, batch a927a02665.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.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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