Catalog Number 623-00-44G |
Device Problems
Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Misassembly by Users (3133)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/16/2015 |
Event Type
malfunction
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Event Description
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During a primary tha the poly would not lock properly into the shell.The surgeon attempted to implant the poly again but it still would not lock in so an immediate backup was used.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor gouging damage on the locking feature indicates debris was present between the mating faces of the liner and shell during insertion and attempted locking.Functional inspection: an accurate functional inspection cannot be performed due to the damage to the locking features from the implantation attempt.Dimensional inspection: an accurate dimensional inspection cannot be performed due to the damage to the locking features from the implantation attempt.The investigation determined, the likely root cause of the event to be debris trapped between the mating faces of the liner and shell during insertion and attempted locking.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
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Event Description
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During a primary tha, the poly would not lock properly into the shell.The surgeon attempted to implant the poly again but it still would not lock in so an immediate backup was used.
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Search Alerts/Recalls
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