Catalog Number 6942-7-065 |
Device Problems
Fitting Problem (2183); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the evaluation summary will be submitted in a supplemental report.
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Event Description
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Primary procedure, hip.It was reported the unitrax c-taper sleeve would not stay on the stem when impacted on.Head remained impacted on the sleeve.The construct was removed and a c-taper lfit head was implanted instead.There was a surgical delay of approximately 10 minutes.
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Manufacturer Narrative
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An event regarding a size/fit issue involving a hip sleeve was reported.The event was not confirmed.Dimensional & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis: material analysis was not performed due to the nature of the event medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
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Event Description
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Primary procedure, hip.It was reported the unitrax c-taper sleeve would not stay on the stem when impacted on.Head remained impacted on the sleeve.The construct was removed and a c-taper lfit head was implanted instead.There was a surgical delay of approximately 10 minutes.
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Search Alerts/Recalls
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