The literature article entitled ¿the radiographic evaluation of keeled and pegged glenoid component insertion¿ by mark d.Lazarus, md; kirk l.Jensen, md; carleton southworth, ms; and frederick a.Matsen iii, md; published in the journal of bone and joint surgery, july 2002, was reviewed.The purpose of the article, was to report on a study to examine the validity of the hypotheses that (1) ideal cementing and seating of glenoid components is inconsistently achieved during shoulder arthroplasty, (2) the serrated, more defined geometry of pegged glenoid components leads to more reproducible cementing and seating, and (3) greater surgical experience contributes to the ability to achieve ideal cementing and seating of the glenoid component.The study involved the global total shoulder system (depuy).According to the radiographs, incomplete seating of the glenoid was common.15 keeled components had ¿worse seating¿ and 85 pegged components had ¿worse seating¿.This study critically evaluated a surgeon¿s ability to perfectly cement and fully seat an all-polyethylene keeled or pegged glenoid component.Surprisingly, perfect cementing and seating of the glenoid component was achieved in only two of the 328 shoulders.The hypotheses of the authors is that a pegged glenoid component has a more fixed geometry than a keeled one, resulting in a more precise fit to host bone.They also conclude that surgeon experience may be an important variable in the achievement of a good technical outcome.The study suggests that improvement in the technical details of glenoid bone preparation and component insertion will increase the surgeon¿s ability to achieve optimal seating and fixation.
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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.Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.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.Device history lot : null.Device history batch : null.Device history review :null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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