Catalog Number 124156025 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Pain (1994); Osteolysis (2377)
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Event Date 02/04/2011 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(b)(4).Followup with the complainant has been conducted for the lot number, and the information is not available.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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Patient was revised to address poly wear and osteolysis.
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Manufacturer Narrative
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This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.
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Event Description
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Patient was revised to address poly wear, osteolysis, and 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.
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Event Description
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Update rec'd 11-oct-2016-medical records received.After review of the medical records for mdr reportability, the revision operative note indicated osteolysis and polywear.There is no new information that would affect the existing mdr decision.This complaint was updated on: 1-nov-2016.
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Manufacturer Narrative
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No device associated with this report was received for examination.The device history records have been reviewed for all product / lot combinations associated with this report.No related deviations or anomalies were identified.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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