Catalog Number UNK-HIP |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Information (3190)
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Event Date 05/21/2015 |
Event Type
Injury
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Event Description
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Patient was revised for pain, increasing metal ion levels, and ultrasound evidence of a pseudotumor.Cup inclination estimated between 25-30 degrees abduction.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Manufacturer Narrative
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No device associated with this report was received for examination.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.Corrective action was not indicated.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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