(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products - g7 acetabular cup catalog#: 110010263 lot#: 3658973, g7 acetabular liner catalog#: 010000982 lot#: 3433505, g7 screw catalog#: 010000999 lot#: 3678645 & 3727754, zimmer femoral stem catalog#: 00784301226 lot#: 62832452.Complaint sample was evaluated and the reported event was confirmed.Dimensional analysis found the device to be within specification, and dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to surgeon misuse, as the stem and head are incompatible.A previous field communication states that these components are not compatible and should not be used together.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.
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