Catalog Number 124154025 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Osteolysis (2377); No Information (3190)
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Event Date 12/29/2015 |
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.(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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Patient was revised to address poly 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.
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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 01/14/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient also had erosion of their calcar.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 01/29/2016.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combinations since release for distribution.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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Event Description
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Update 01/27/2016 x-rays review findings shows patient had osteolysis.There is no new information that would change the existing mdr decision.Complaint was updated 02/04/2016.
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Search Alerts/Recalls
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