STRYKER ORTHOPAEDICS-MAHWAH HMRS AXIS PIN; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6366-9-220 |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 05/20/2022 |
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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Revision (hmrs parts replacement after 12 years) according to bfarm special approval.Update 25may22, after 12 years , the poly is worn out.There was a massive instability in the knee joint.Especially the stopper on the proximal tibia was very crushed.
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Manufacturer Narrative
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Reported event: an event regarding instability involving a hmrs axle was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device is damaged along the rim of the pin.This damage is likely due to contact with explantation tooling.-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: it was reported that the patient was revised due to worn poly components and joint instability.Visual inspection of the returned device indicated that the device is damaged along the rim of the pin.This damage is likely due to contact with explantation tooling.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 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Revision (hmrs parts replacement after 12 years) according to bfarm special approval.Update (b)(6) 2022 after 12 years , the poly is worn out.There was a massive instability in the knee joint.Especially the stopper on the proximal tibia was very crushed.
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