The literature article entitled ¿computer navigated versus conventional total knee arthroplasty¿ written by japp j.Tolk, md, et al, published in the journal of knee surgery on 3 may 2012, doi: http://dx.Doi.Org/10.1055/s-0031-1299670, was reviewed.The purpose of the study was to compare the accuracy of alignment reconstruction using conventional and computer-assisted placement of tka.The effect of cas on functional outcome was also analyzed.Depuy product used: lcs tka.There were 50 conventional (conv) and 50 computer assisted (cas) tka¿s performed with follow-up.There was patellar resurfacing in (5) cases.Cement manufacturer not noted.There were (8) complications in the conv group and (6) complications in the cas group.Adverse events were as follows: conv group: postoperative delirium, postoperative cerebral infarction, delayed wound healing, superficial wound infection, deep infection, additional surgery to remove drain and revision surgery with adhesiolysis.Cas group: postoperative atrial fibrillation, arthrofibrosis, delayed wound healing, peroneal palsy, vasovagal syncope and patellar resurfacing for anterior knee pain.
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Product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.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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