Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
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Event Date 12/01/2007 |
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, "complex revision total hip arthroplasty with modular stems at a mean of 14 years" written by joseph c.Mccarthy, md and jo-ann lee, ms published by clinical orthopaedics and related research number 465, pp.166-169 published december 2007 was reviewed.The article's purpose was to discuss findings on srom modular femoral stems at mid to long-term follow ups.Data was compiled from 87 patients (92 hips) implanted between 1989 and 1993.Depuy products utilized: srom (stem and sleeve).Adverse events: loose stems treated by revision, mild calcar resporption noted along with proximal lysis all treated by revision, infection and sepsis treated by interim staged resection arthroplasty.
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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.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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Manufacturer Narrative
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Product complaint # (b)(4).(b)(4) used to capture medical device removal.
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Search Alerts/Recalls
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