(b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record could not been reviewed as the lot number was not correct.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.The product analysis can't be performed as the product was not returned.A retain sample of batch 902aa02660 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 could not be reproduced.Therefore, the reported event could not be confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.2 complaints (2 products), this one included, have been recorded on optipac 80 refobacin bone cement r, reference 4712500398-3, batch 902aa02660 regarding mixing issue.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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