The literature article entitled, "short term patient outcomes after total knee arthroplasty: does the implant matter?" written by ilda b.Molloy, benjamin j.Keeney, michael b.Sparks, nicholas g.Paddock, karl m.Koenig, wayne e.Moschetti, and david s.Jevsevar published by the knee (2019) 687-699 accepted by publisher 27 january 2019 was reviewed.The article's purpose "was to compare two different tka implants using patient-reported outcomes." data was compiled from 2116 total knee arthroplasties of primary unilateral and bilateral tkas implanted between april 2011 through july 2016.Cement manufacturer was not identified.Patella resurfacing was not reported.Depuy products utilized: sigma knee system, attune knee system adverse events associated with sigma knee system: wound dehiscense treated by re-operation, infection treated by re-operation, patellar maltracking treated by re-operation adverse events associated with attune knee system: wound dehiscense treated by re-operation, infection treated by re-operation, hemarthrosis treated by re-operation.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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