STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LEFT KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
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Event Date 11/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding loosening involving an unknown right knee 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 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.H3 other text : device not returned to the manufacturer.
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Event Description
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This is for continued loosening, longer scar, swelling, fluid & pain, poor flexibility and impending revision.It was reported through stryker facebook page: "had my left knee replaced march of 2022.Revision april of 2023.Scheduled for another revision november of 2023." update per additional comment received: "going in soon for my 2nd revision.First surgery and first revision done with mako.Both resulted with same results loose, longer scar, swelling & fluid, pain and poor flexibility.".
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