Catalog Number 124148025 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 12/05/2014 |
Event Type
Injury
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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.
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Event Description
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Hip revision performed on (b)(6) 2014 due to wear.
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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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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.A complaints database search and review of manufacturing records did not identify any anomalies.The complaint shall be closed with an undetermined conclusion; it will be entered into the complaint database and monitored through trend analysis.
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Search Alerts/Recalls
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