A review of the implant's manufacturing record indicates that it was manufactured to specification.The deep vein thrombosis is being treated with anticoagulation as per the reporting information.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.Remains implanted.
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This follow-up report is being submitted to relay additional information.Concomitant medical products: pn#: 42500806202, trabecular metalâ¿¢ posterior stabilized monoblock tibial component: green, size 5 e-f, 10mm, lot#: 63208575 pn#: 42500806202, femur trabecular metal posterior stabilized (ps) standard porous, lot#: 63680778.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is determined to be procedure related and unrelated to the devices.
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