Catalog Number 149801004 |
Device Problems
Loss of Osseointegration (2408); Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Pain (1994); Joint Swelling (2356); No Code Available (3191)
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Event Date 03/31/2014 |
Event Type
Injury
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Event Description
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Clinical report states patient was revised to address chronic pain.
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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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.
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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 at this time.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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