(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided: product evaluation could not be performed.Review of the manufacturing records identified no deviations or anomalies during manufacturing related to the reported event.Device used for treatment.Medical records were received and reviewed.The patient is male, at the time of the reported event he is 44 years old.The patient underwent a first bilateral tha because of dysplastic arthrosis at both sides.Both cups have been implanted with a low inclination (as well as a low anteversion.With the available data a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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