Catalog Number 625-0T-32E |
Device Problems
Device Slipped (1584); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/04/2014 |
Event Type
Injury
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Event Description
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It was reported that there was a revision of a right ceramic/ ceramic liner and head due to squeaking.
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Manufacturer Narrative
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The catalog number and lot code were not provided.The device was reported as an unknown ceramic liner.A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Evidence of femoral neck impingement damage was observed on the rim of the sleeve component.A wear scar was observed throughout a majority of the articulating surface area.Dimensional inspection was performed as part of the mar.The results show that the diameter of the insert component did not meet the drawing requirements of a new component, most likely due to in vivo service.The mar report concluded: no material or manufacturing defects were observed on any of the components examined.Both the ceramic head and insert showed evidence of wear scars.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays and the operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.
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Event Description
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It was reported that there was a revision of a right ceramic/ ceramic liner and head due to squeaking.
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Search Alerts/Recalls
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