Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/16/2020 |
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.
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Event Description
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Revision of left total hip with ultamet liner due to metallosis.Removed liner, cup, and head.Converted to dual mobility.
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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 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.Device history lot: a device history record (dhr) review, was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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