The literature article entitled ¿analysis of severely fractured glenoid components: clinical consequences of biomechanics, design, and materials selection on implant performance¿ by farzana ansari, phd; taylor lee, louis malito, ms; audrey martin, bs; stephen b.Gunter, md; samuel harmsen, md; tom r.Norris, md; mike ries, md; douglas van citters, phd; and lisa pruitt, phd; published in the journal of shoulder and elbow surgery, in 2015 was reviewed.The article was based on 16 retrieved glenoids with severe fracture were analyzed after explant.All implants were catastrophic failures.The glenoids span the evolution of tsr design and material variables during the past 20 years.The authors contend that modern hxl glenoid components are still at risk of catastrophic fracture in vivo in currently available tsrs.Out of the 16 implants, ten were from depuy and all were pegs.All glenoids were made of hylamer but one, which was cross linked.The article contains a table that breaks down each implant, patient age and sex, time in vivo, radial mismatch and minimum thickness.The cases are listed below: (b)(6) y/o male, (b)(6) years, 3-mm radial mismatch,.37 minimum thickness.
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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 : no device associated with this report was received for examination, however, photographs of the subject complaint sample were provided for review confirming the reported event.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.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 will be filed as appropriate.
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