MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180503 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 12/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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A supplemental report will be submitted if additional information becomes available.
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Event Description
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Revision of mako left medial knee.Femoral component was loose although not grossly.Abnormal wear on the tibial insert.
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Manufacturer Narrative
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An event regarding loosening involving a mck femoral-rm-ll-sz 3 was reported.The event was not confirmed.Method & results: -device evaluation and results: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.A material analysis was performed and indicated "nothing remarkable was observed on the femoral component.Burnishing, scratching and third-body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as medical records were not received for review with a clinical consultant.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because insufficient medical information was provided.A material analysis was performed and indicated "nothing remarkable was observed on the femoral component.Burnishing, scratching and third-body indentations were observed on the articulating surface of the insert.These are common damage modes of uhmwpe.No material or manufacturing defects were observed on the surfaces examined." if additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Revision of mako left medial knee.Femoral component was loose although not grossly.Abnormal wear on the tibial insert.
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Search Alerts/Recalls
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