STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER TKR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Ambulation Difficulties (2544); Unequal Limb Length (4534); Insufficient Information (4580)
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Event Date 04/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event involving an unknown knee implant 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 remains implanted.Clinician review: no medical records were received for review with a clinical consultant.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 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.H3 other text : device not returned.
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Event Description
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It was reported through strykeractive's facebook page: "my 6 month old stryker / mako tkr isn't going well".
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Event Description
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It was reported through strykeractive's facebook page: "my 6 month old stryker / mako tkr isn't going well" update per additional post received: "hamstring attachment issues 10 months later.And slight leg length/gait issues that have created metatarsal issues.I give the surgery a b grade.".
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Manufacturer Narrative
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Reported event: an event regarding limb length discrepancy involving an unknown knee implant 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 remains implanted.Clinician review: no medical records were received for review with a clinical consultant.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 pathology reports, pre- and post-operative x-rays 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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