Catalog Number 625-0T-32F |
Device Problems
Corroded (1131); Material Discolored (1170); Insufficient Information (3190); Noise, Audible (3273)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 11/16/2016 |
Event Type
Injury
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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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Event Description
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Primary tha surgery using ceramic liner was performed on (b)(6) 2007.The revision surgery was performed on (b)(6) 2016 because the patient complained of squawking.During the revision, the surgeon found a discoloration like a corrosion on the metal of the ceramic liner.The corrosion investigation has been requested.
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Manufacturer Narrative
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An event regarding squeaking and corrosion involving an trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the returned device showed no evidence of discoloration or corrosion.Some damage consistent with explantation damage was observed on the rim of the liner.-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 exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, patient history, progress notes and x-rays 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 tha surgery using ceramic liner was performed on (b)(6) 2007.The revision surgery was performed on (b)(6) 2016 because the patient complained of squawking.During the revision, the surgeon found a discoloration like a corrosion on the metal of the ceramic liner.The corrosion investigation has been requested.
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Search Alerts/Recalls
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