STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 623-00-36G |
Device Problems
Difficult to Insert (1316); Material Distortion (2977)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that in performing a mako primary left hip procedure, surgeon attempted to implant a g liner.The liner would not snap into the shell.Another liner was procured, which did snap into the shell, causing a surgical delay of approximately 3 minutes.
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Manufacturer Narrative
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An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis engineer indicated, "damage observed on distal rim of insert, likely due to implantation/explantation process.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation could not be confirmed as the device was returned damaged.Further information such as details of the shell and the operative report are needed to complete the investigation for determining root cause.No further investigation is possible at this time as insufficient information was received.If additional information becomes available the investigation will be reopened.
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Event Description
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It was reported that in performing a mako primary left hip procedure, surgeon attempted to implant a g liner.The liner would not snap into the shell.Another liner was procured, which did snap into the shell, causing a surgical delay of approximately 3 minutes.
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Search Alerts/Recalls
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