(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Images of ap x-rays of the left hip + pelvis were received, with one of the x-rays showing the hip in internal rotation.The femoral head doesn't appear to be dislocated or show any signs of dislocation in these x-rays.No conspicuousness can be seen.Based on the investigation and received x-rays, the reported event of dislocation cannot be confirmed.Based on the given information and the results of the investigation, unable to identify a specific root cause for this 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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