(b)(4).Foreign report source: (b)(6).The device will not be returned to the manufacturer.Therefore, it will not be analyzed.Reserve sample from the same lot was tested under standardized conditions.The product did not show any unusual behavior during mixing, handling or setting.The reported behavior of the cement could not be reproduced.The review of the device manufacturing quality record indicates that 2912 products optipac 40 refobacin plus bone cement-3, reference 4720502083-3, lot number 817ba08660 were manufactured on 04 june 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.2 other complaints have been recorded for optipac reference 4720502083-3, lot number 817ba08660 on the reported event within one year.With the available information, the exact root cause of the event could not be determined.An investigation has been performed, consisting of a documentary review and a reserve sample analysis.The documentary review showed that product was manufactured according to the pre-defined specifications of biomet france.The reserve sample analysis did not show any unusual behavior during mixing, handling or setting.According to available data, the exact root cause can¿t be determined.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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