STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inadequate Osseointegration (2646); Insufficient Information (4580)
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Event Date 08/04/2022 |
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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It was reported by the sales rep that surgeon called up to discuss a possible removal of implants case.Patient had surgery in 2009, hence no product details can be found.X-ray showed it is possible devices are stryker implants.
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Event Description
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It was reported by the sales rep that surgeon called up to discuss a possible removal of implants case.Patient had surgery in 2009, hence no product details can be found.X-ray showed it is possible devices are stryker implants.Update: reason for revision: aseptic loosening (right side).
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Manufacturer Narrative
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Reported event: an event regarding loosening involving an unknown knee was reported.This 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: a review of provided medical records with clinical consultant indicated the event and root cause cannot be confirmed.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: 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 primary 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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