Catalog Number 180608 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 05/27/2015 |
Event Type
Injury
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Event Description
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(b)(6) revised a left medial mako pka originally done on (b)(6) 2012 to a stryker triathlon cementless.Merchant claimed the patient formed lateral compartment disease.The mako pka implants were well fixed he noted.
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Manufacturer Narrative
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Review of device history records indicates the lot was manufactured and accepted into final stock on 28-feb-2012.A complaint history review was not performed as the indication for revision was not provided; no device specific failure modes were identified.The event could not be confirmed nor the root cause of the reported revision surgery determined due to the minimal information received.The clinical indication for the revision was not provided.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
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Event Description
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(b)(6) revised a left medial mako pka originally done on (b)(6) 2012 to a stryker triathlon cementless.(b)(6) claimed the patient formed lateral compartment disease.The mako pka implants were well fixed he noted.
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Search Alerts/Recalls
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