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Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Loss of or Failure to Bond (1068); Use of Device Problem (1670); Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); Hematoma (1884); 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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Literature article entitled: "primary total hip arthroplasty using an anterior approach and a fracture table¿.The article reviews the short term results of 247 total hip replacements from a community hospital by 5 surgeons with limited experience in the anterior approach.152 depuy synthes femoral stems were utilized (42 cemented summit, 77 cementless summit, 19 corail ha coated, 12 trilock, and 3 srom).The manufacturers of the cup and liner were not provided.Post-operative complications included 4 hematomas, 2 calcar fractures, 2 superficial infections, 2 femoral shaft fractures, 14 proximal femoral or gt fractures, 2 deep infections, 2 nerve palsys, 3 with immediate need for revision due to leg length discrepancy, 3 femoral revisions within a year, 5 femoral subsidence within a year, and 8 total femoral loosenings.18 femoral stems demonstrated more than 5 degrees of varus.
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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.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.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 will be filed as appropriate.
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Search Alerts/Recalls
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