STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 702-04-52E |
Device Problem
Malposition of Device (2616)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 10/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding malposition involving a trident ii shell was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to due to psoas impingement.Intraoperatively, abnormal wear was noted on the elevated rim of the liner.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the patient's left hip was revised due to psoas impingement.Intraoperatively, abnormal wear was noted on the elevated rim of the liner (exact cause of wear unknown).A shell, liner and head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
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