Catalog Number UNK HIP ACETABULAR CUP |
Device Problems
Off-Label Use (1494); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 07/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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The literature article entitled, "cementing constrained liners into secure cementless shells: a minimum 15-year follow-up study" written by grant h.Young, bs, matthew p.Abdel, md, richard l.Amendola, be, ms, devon d.Goetz, md, david g.Lewallen, md, and john j.Callaghan, md published by the journal of arthroplasty available online 18 july 2017.The article's purpose was to determine the durability of a cementless acetabular fixation in total hip arthroplasty construct at minimum 15 year follow up.Data was compiled from 30 patients with 31 hips performed between december 1, 1988 and october 30, 2000.It is noted that non-depuy constrained poly liners were cemented into depuy (quantity 1) and non depuy cups (remainder).Therefore, it is assumed that all other components such as femoral components were non-depuy.Cement manufacturer was not identified.The article does not specify which products are related to the adverse events.Most of the adverse events involved the non-depuy products (broken constraining ring, disassociated liner, dislocation, loose stem) with the exception of one case of infection.Depuy product: quantity 1 duraloc trispike cup.Adverse event: infection (treated by revision).
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Manufacturer Narrative
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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.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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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.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will 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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Search Alerts/Recalls
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