Catalog Number 999800315 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Scar Tissue (2060); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 03/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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Asr medical records received.There were no harms reported.Medical records provided the primary surgery only, there were no revision notes included.Shall there be new information received this complaint will be updated.Doi: (b)(6) 2008; dor: none reported; (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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