Literature article entitled, ¿computer-assisted total knee arthroplasty: impact of the surgeon¿s experience on the component placement¿ by richard ballas, et al, published by archives od orthopaedic trauma surgery (2013), vol.133, pp.397-403, was reviewed.The purpose of this study was to assess the accuracy of implant positioning in computer assisted unicompartmental lcs tka in novice users compared with experienced users.The novice cohort involved 91 knees implanted between august 2004 and october 2008.The experienced cohort included 194 knees implanted between january 2005 and september 2007.The following results did not include patient identifiers.Depuy products: depuy lcs unicompartmental total knee arthroplasty including a femoral component, polyethylene tibial component, and tibial tray.There was no indication that the patella was resurfaced, and the cement utilized is unknown.Radiographic results: unknown number of femoral and tibial components were implanted in varus/valgus to a degree outside of the acceptable range for component alignment.Results: 1 intraoperative tubercle fracture- treatment unspecified.1 report of persistent postoperative patellar pain- treatment unspecified.1 revision to treat polyethylene insert dislocation.Actual components revised is unknown.Captured in this complaint: tibial tray and femoral component for mispositioning femoral component and tibial insert for implant dislocation, pain tibial tray for pain and periprosthetic fracture.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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