Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Code Available (3191)
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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, "cellular mediators secreted by interfacial membranes obtained at revision total hip arthroplasty" written by arun s.Shanbhag, phd, joshua j.Jacobs, md, jonathan black, phd, jorge o.Galante, md, and tibor t.Glant, md, phd published by the journal of arthroplasty vol.10 no.4 1995 was reviewed.The article's purpose to report the cytokine/cellular mediator aspect from cemented and non cemented thas.It is noted that table 1 is a table of revisions and 3 cases are identified with depuy products.Each case is captured individually in linked complaints.Only stems are identified and they are all cemented with no further information provided regarding on the adverse events.Cement manufacturer not identified and specific loosening interface is not identified.This complaint captures cemented case 1 of (b)(6) male that received revision to aml stem for aseptic loosening.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: 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.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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