Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 09/01/2005 |
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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"literature article entitled, ¿modular junctions¿ by hugh u.Cameron, mb, chb, frcs(c), faaos, published by orthopedics (2005), vol.28, no.9/supplement, was reviewed.The purpose of this article was to determine if the proximal seal on the s-rom stem was able to prevent distal stem osteolysis by blocking polyethylene debris created by wear of a polyethylene liner.Implants: s-rom stem with s-rom proximal sleeve.The manufacturer of the acetabular components and femoral head are unknown.Results: there were three patients that had distal femoral osteolysis at final follow-up.One patient died of unrelated causes before revision surgery.One patient experienced a periprosthetic fracture through the distal osteolysis and was revised to al long stem, which remained asymptomatic at 9 years follow-up.One patient required revision surgery.Of the stem.All three patients with distal osteolysis had initial inadequate osseointegration of the proximal sleeve that resulted in radiolucent lines between the sleeve and bone which allowed access of polyethylene debris resulting in distal osteolysis.In the three revision surgeries, the proximal sleeve was adequately osseointegrated and left in situ.Captured in the complaint: 3 revisions of the s-rom stem due to distal osteolysis and one periprosthetic fracture.3 s-rom augments with initial inadequate osseointegration requiring no revision surgery.The acetabular components-including the polyethylene liner-and the femoral head are unknown and therefore not captured in this complaint.".
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision depuy synthes 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.Product complaint # (b)(4).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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