(b)(4).Concomitant medical products: zimmer head cat#00801803601 lot#62374415, zimmer stem cat#00784301582 lot#60512873, zimmer liner cat#00630505636 lot#62379571, zimmer cup cat#00620205622 lot# 62196365.Reported event was confirmed with x rays provided.Review of the available records identified the following : there was minimal radiolucency at the cement hardware interface of the proximal femur suggesting early loosening.Extensive heterotopic ossification within the surrounding soft tissues of right hip and mild osteopenia were noted.No other abnormalities were observed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00395.
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