Model Number 1365-51-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); No Code Available (3191)
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Event Date 10/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Pinnacle claim submission form and medical records received.After review of medical records the patient was revised to address unspecified osteoarthritis type.Operative note reported yellowish-brownish thick fluid however no infection, some what appeared to be pseudotumor, granulation and necrotic tissue but no significant metallosis.Doi: (b)(6) 2009; dor: (b)(6) 2019; left 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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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