(b)(4).X-rays were provided, but were found to be non-relevant to the reported event.Medical records were not provided for review.It was reported however, that the surgeon believes the reason for device failure was due to medical issues with the patient.The patient has some problems with her lower extremities and is reliant on her upper extremities to assist in standing from a sitting position.The reported event cannot be confirmed from this information.Review of the device history records identified no deviations or anomalies during manufacturing.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.Event occurred in (b)(6).
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