(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned parts determined that they had scratches suggesting repeated use.Sem micrographs and eds elemental analysis of the debris on the femoral provisionals was conducted and it was found that rust like indication on the laser etched areas which showed high concentration of (o- oxygen, mn-manganese and cl-chlorine) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed chlorine- cl, carbon-c, silicon- si, calcium-ca and aluminum-al.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Investigation results concluded that the reported event was due to maintenance issue as some of the chemical elements do not come from the instruments, but could come from hard water.The black residue is spread on each and all the instruments, which is only possible through contact with air and water.The recommended cleaning steps were not followed based on the provided information.A summary of the investigation has been sent to the complainant.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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