(b)(4).This follow-up report is being filled to relay additional information.No product was returned to zimmer biomet for in-depth analysis.The review of the device manufacturing quality record indicates that (b)(4) products optipac-s 60 refobacin plus bone cement, reference (b)(4), lot number a703a07285 were manufactured on 24 may 2017, 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 complaints have been recorded for optipac, batch a703a07285 within one year.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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