Model Number N/A |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 07/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(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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Event Description
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It was reported that following non integration of the biomaterial, the bone material was not compacted causing an implant failure.The biomaterial was placed on (b)(6) 2017, the implant was placed on (b)(6) 2017 and non integration appeared on (b)(6) 2018.
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Event Description
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It has been reported that following non integration of the biomaterial, the bone material was not compacted causing an implant failure.The biomaterial was placed on (b)(6) 2017, the implant was placed on (b)(6) 2017 and non integration appeared on (b)(6) 2018.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.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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Search Alerts/Recalls
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