(b)(4).Foreign report source: (b)(6).The reported event was unable to be confirmed as the product was not returned.The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that 5912 products désignation refobacin bone cement r40x1, reference 3003940001, batch a701ba2601 were manufactured on 18/10/2017.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 complaint event described in the complaint.21 similar complaints have been recorded for refobacin bone cement r 1x40g, batch a701ba2601 within one year.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.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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