(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact 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.
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It was reported that following a non integration of the biomaterial, the bone material was not compacted, which resulted in implant failure.The biomaterial was placed on (b)(6) 2017, implant was placed on (b)(6) 2018 and non integration appeared on (b)(6) 2018.
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