Catalog Number 123430000 |
Device Problem
Fracture (1260)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 09/23/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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Patient received several neuflex prothesis on right hand.All had to be revised because of fracture.
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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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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 18 october 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, upon revision synovitis was noted in mcp-2.Mcp2-5 were found to have destruction of the neuflex prosthesis and mcp-5 was noted to be broken.At this time there is no new information that would change the existing mdr decision.
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Manufacturer Narrative
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Examination of the submitted device confirmed fracture through the hinged area.No fracture features could be identified and therefore a cause of failure could not be determined.No material defects or inclusions were noted that would have contributed to the failure of the implants.No evidence was found indicating product error was a contributing factor to the fractured devices and the need for 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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