Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problems
Corroded (1131); Degraded (1153); Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 10/25/2009 |
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, ""corrosion at the stem-sleeve interface of a modular titanium alloy femoral component as a reason for impaired disengagement"" written by christian r.Fraitzl, md, luis e.Moya, md, lorenzo castellani, md, timothy m.Wright, phd, and robert l.Buly, md published by the journal of arthroplasty vol.26 no.1 2011 accepted by publisher october 25, 2009 was reviewed.The article's purpose was to report on examination of 22 modular titanium alloy femoral components retrieved.0 to 8.8 years in vivo.All implants were the srom stem.The article does not discuss or provide any information regarding femoral head, acetabular cups or bearing surfaces.The main focus was the retrieved stem with examination of the sleeve/stem interface for corrosion.Each case is captured individually along with reason for revision and note of corrosion." this complaint captures specimen 13 from a (b)(6) year old with implantation period of 2.8 years 11 mm stem size and reasons for revision was loosening of femoral component.Note of corrosion with black metal debris noted on stem and sleeve interface.
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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.H10 additional narrative: added: h6 (device) correction: h6 (device) 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 - 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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Search Alerts/Recalls
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