Catalog Number 6570-0-132 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that in performing a primary hip (side not reported) procedure, the 32mm +0 head would not lock onto the accolade ii stem.The head was able to be manually removed by the surgeon.Another head was immediately available and locked onto the stem with no issues.Rep reported that no case time was lost (no surgical delay).
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Manufacturer Narrative
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An event regarding a size/fit issue involving a ceramic head was reported.The event was not confirmed.Dimensional inspection: a dimensional inspection was performed on the returned device where all dimensions were found to be within specification.Functional inspection: not performed as the exact failure mode could not be replicated.Material analysis: not performed as the reported event is not related to material integrity of the device.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.Further information such as operative reports are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
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Event Description
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It was reported that in performing a primary hip (side not reported) procedure, the 32mm +0 head would not lock onto the accolade ii stem.The head was able to be manually removed by the surgeon.Another head was immediately available and locked onto the stem with no issues.Rep reported that no case time was lost (no surgical delay).
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Search Alerts/Recalls
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