Catalog Number UNK HIP FEMORAL STEM |
Device Problem
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 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.
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Event Description
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"the literature article entitled, ""cementless femoral revision arthroplasty 2 to 5 year results with a modular titanium alloy stem"" written by jason a.Smith, md, harold k.Dunn, md, and b.J.Manaster, md published by the journal of arthroplasty vol.12 no.2 1997 was reviewed.The article's purpose was to review the results of a consecutive series of cementless femoral revisions that were followed prospectively.Data was compiled from revision surgeries between october 1988 to december 1991 with 35 male and 31 female patients with average age at time of surgery of 64.5 years.It is noted that the only depuy product utilized with srom femoral stem and all other components were non-depuy used in conjunction with the srom stem.The article reports generalized outcomes/adverse events and also identifies 2 patients with identifiers in radiographic images that are captured individually in linked complaints.Depuy products utilized: srom stem" this complaint captures the (b)(6) woman in radiographic image who received re-revision due to infection to a non-depuy stem 24 months post initial revision surgery.
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Manufacturer Narrative
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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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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