STRYKER ORTHOPAEDICS-MAHWAH GUEPAR I-II. CIRCLIP; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 2080-04 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Joint Laxity (4526); Insufficient Information (4580)
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Event Date 12/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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Clip disengaged.The patient has had multiple revisions prior so revision is undecided now.
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Event Description
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Clip disengaged.The patient has had multiple revisions prior so revision is undecided now.
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Manufacturer Narrative
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Reported event: an event regarding disassociation involving a guepar i-ii circlip was reported.The event was confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review with clinical consultant indicated "confirmation: it does appear that there is a loose clip floating freely in the knee on a single view image.The nature of the clip cannot be determined.Root cause: a root cause cannot be ascertained from the materials provided for review." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: clinician review of provided x-rays confirmed the reported event.No further investigation for this event is possible at this time.If 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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