(b)(4).Radiographs were provided and reviewed by a health care professional.Review of the available records identified an undersized femoral head, possible partial dislocation and possible loosening of the femoral stem.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause could not be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 01704 and 0001822565 - 2022 - 01705.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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