STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 502-11-48D |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 11/29/2023 |
Event Type
Injury
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Event Description
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Patient is status post right total hip revision completed today due to hip pain/ possible aseptic loosening.All components removed today except for stem.Competitor utilized for cup, screws, liner.
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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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text : device not returned.
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Event Description
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Patient is status post right total hip revision completed today due to hip pain/ possible aseptic loosening.All components removed today except for stem.Competitor utilized for cup, screws, liner.Update: intraoperatively, loosening was not observed by the surgeon.
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Manufacturer Narrative
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An event regarding pain involving a trident 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 pain.Aseptic loosening was suspected but this was not observed by the surgeon during the revision.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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Search Alerts/Recalls
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