STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN STRYKER KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problems
Fracture (1260); Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 01/27/2022 |
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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During follow-up for revision of the patient's right knee on (b)(6) 2022, rep confirmed that a prior right stryker knee revision was performed on (b)(6) 2022 due to "component failure.".
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Manufacturer Narrative
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Reported event: an event regarding loosening and fracture 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 x-ray dated (b)(6) 2022 prior to revision procedure on (b)(6) 2022 with a clinical consultant indicated "i can confirm that this event took place since i was able to view the xrays of the fracture and the bent stem.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of periprosthetic fracture are multifactorial including surgical technique factors, trauma, and patient factors.Causes of a deformed or bent stem are also multifactorial including surgical technique factors, failure of adequate fixation, trauma, and implant factors." -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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Event Description
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During follow-up for revision of the patient's right knee on (b)(6) 2022, rep confirmed that a prior right stryker knee revision was performed on (b)(6) 2022 due to "component failure.".
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Search Alerts/Recalls
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