Catalog Number 5531G411 |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2015 |
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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Surgeon felt 411 cs x3 insert did not seat properly.It was explanted and a replacement 411 cs x3 was implanted successfully.
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Manufacturer Narrative
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An event regarding a seating/locking issue involving a triathlon insert was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection of the returned component indicates that the types of damage observed on the insert are indicative of an obstruction on the posterior aspect of the insert which may have been the reason that the user failed to position the insert correctly on the baseplate.Medical records received and evaluation: not performed as no medical records were provided.Device history review: dhr review for the reported lot was satisfactory.Complaint history review: chr review for the reported lot confirmed that there are no other similar events reported.Conclusions: based on the visual inspection of the returned component, it appears that an obstruction on the posterior aspect of the insert may have been the reason that the user failed to position the insert correctly on the baseplate.No further investigation for this event is required at this time.
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Event Description
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Surgeon felt 411 cs x3 insert did not seat properly.It was explanted and a replacement 411 cs x3 was implanted successfully.
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Search Alerts/Recalls
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