Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Degraded (1153); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); No Code Available (3191)
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Event Date 01/20/2012 |
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, "large-diameter modular metal-on-metal total hip arthroplasty" written by william p.Barrett, md, kirk a.Kindsfater, md, and james p.Lesko published by the journal of arthroplasty vol.27 no.6 2012 accepted by publisher 20 january 2012 was reviewed.The article's purpose is to present the results of 4 clinical trials with modular mom bearing total hip system with special focus on the small subset of revisions attributed to an armed (adverse reaction to metallic debris).The data was compiled from 4 studies of 779 thas and pulled 22 revision cases.All cases had depuy products and each case is captured individually in linked complaints.Depuy products: stem (various and identified individually), pinnacle cup, ultamet metal liner, metal femoral head this complaint captures case #1 (b)(6) male with summit stem and received revision 2.9 years post initial implantation for pain and positive findings of armed.Narrative description provides further detail of findings of corrosion on both the head and stem of the head/stem junction but head and liner were only exchanged to mop bearings.His frozen section revealed necrotic tissue and fibrous tissue consistent with a pseudotumor-type reaction.No infection.
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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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Search Alerts/Recalls
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