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Catalog Number 74122544 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Toxicity (2333); Injury (2348)
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Event Date 03/01/2019 |
Event Type
Injury
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Event Description
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Patient submitted medwatch mw5086994 reports right hip revision due to pseudotumour, metal toxicity and dislocation.2 further revision surgeries reported on the right side, part details unknown.
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Manufacturer Narrative
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Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
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Search Alerts/Recalls
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