DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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Catalog Number 157011120 |
Device Problems
Corroded (1131); Biocompatibility (2886)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 02/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation : lawyer.
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Event Description
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Update ad 05 apr 2019.Asr litigation records received alleging elevated blood heavy metal ion levels, injury, pain and suffering.Update ad 10 apr 2019.Medical records received.After review of medical records, the patient was revised to address a failed left total hip replacement secondary to metal-on-metal wear.Operative findings include a large pseudotumor, corrosion on the trunnion, abundant amounts of fluid with whitish debris and scar tissue.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions 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.
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Manufacturer Narrative
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Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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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