Catalog Number 623-00-36D |
Device Problems
Use of Device Problem (1670); Fitting Problem (2183); Mechanics Altered (2984); Misassembly by Users (3133)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2015 |
Event Type
malfunction
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Event Description
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The customer reported that when the surgeon was implanting a trident liner, the device allegedly appeared to be misshapen and did not fit the trident shell.The customer further reported that another device (same product code and lot number) was used to complete the case and that did fit the shell.Opening a second device resulted in a 10 minute delay to surgery.There were no other adverse consequences for the patient.
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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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Review of device history records indicates the lot was manufactured and accepted into final stock.There have been no other events for the lot referenced.The subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor indentation damage is noted all around the back side of the device on both the hemispherical surface and the locking face.This damage appears consistent with debris trapped between the liner and shell.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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The customer reported that when the surgeon was implanting a trident liner, the device allegedly appeared to be misshapen and did not fit the trident shell.The customer further reported that another device (same product code and lot number) was used to complete the case and that did fit the shell.Opening a second device resulted in a 10 minute delay to surgery.There were no other adverse consequences for the patient.
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Search Alerts/Recalls
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