STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Unintended Movement (3026)
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Patient Problem
Pain (1994)
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Event Date 02/29/2024 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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It was reported through stryker facebook page: i had my knee replacement last (b)(6) 2023 and have nothing but pain everyday.I feel like a cripple.Had another ortho dr look at it and was told the plastic in between the metal is too thin and my knee is shifting causing "slight opening to varus stress mid flexion."the option i was given is a revision surgery with no guarantee this will help me.The reason i chose a robotic assisted surgery was to be assured the size and placement would be accurate.I reached out to stryker and did not get a return call.Additional facebook comment received, "my mako surgery did not go well.The plastic part in my knee joint is too thin and my knee is shifting and i've been in pain for almost 11 months now.".
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Event Description
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It was reported through stryker facebook page: i had my knee replacement last (b)(6) 2023 and have nothing but pain everyday.I feel like a cripple.Had another ortho dr look at it and was told the plastic in between the metal is too thin and my knee is shifting causing "slight opening to varus stress mid flexion."the option i was given is a revision surgery with no guarantee this will help me.The reason i chose a robotic assisted surgery was to be assured the size and placement would be accurate.I reached out to stryker and did not get a return call.Additional facebook comment received, "my mako surgery did not go well.The plastic part in my knee joint is too thin and my knee is shifting and i've been in pain for almost 11 months now." additional fb comment received , "i just learned that the stryker knee that i have has the wrong size plastic part and it's causing my knee to shift and giving me continual pain.".
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Manufacturer Narrative
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An event regarding subsidence involving an unknown knee component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review:no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, xrays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be reopened.
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Search Alerts/Recalls
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