Catalog Number 180603 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 02/06/2017 |
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 at the later time it will be reported in a supplemental report upon completion of the investigation.Not returned to manufacturer.
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Event Description
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Dr (b)(6) revised a mako unicondular knee originally implanted on (b)(6) 2016 by dr (b)(6).Dr (b)(6) explanted the uni and converted to a tka.The tibial implant was found to be loose and acl was found to be compromised.
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Manufacturer Narrative
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An event regarding pain and loosening involving an mako baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: 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 the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Dr (b)(6) revised a mako unicondylar knee originally implanted on (b)(6) 2016 by dr (b)(6).Dr (b)(6) explanted the uni and converted to a tka.The tibial implant was found to be loose and acl was found to be compromised.
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Search Alerts/Recalls
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