Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); No Code Available (3191)
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Event Date 04/21/2007 |
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, "intraoperative femur fracture risk during primary direct anterior approach cementless total hip arthroplasty with and without a fracture table" written by eric m.Cohen, md, joshua j.Vaughn, md, scott a.Ritterman, md, daniel l.Eisenson, bs, and lee e.Rubin, md published by the journal of arthroplasty 32 (2017) 2847e2851 http://dx.Doi.Org/10.1016/j.Arth.2017.04.020 on 21 april 2017 was reviewed for mdr reportability.The article reports upon intraoperative femur fractures noting depuy products associated with 12 cases with patient identifiers listed in two different tables.Table 2 is intraoperative femur fracture in direct anterior approach with a fracture table and table 3 is intraoperative femur fracture in direct anterior approach without a fracture table.This complaint captures the fourth patient and the remaining 11 are captured on linked complaints: (b)(6) year old female with a corail stem suffered a medial perforation and treated with revision femoral stem (table 2).
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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).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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