Catalog Number 101012070 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problems
Cardiac Arrest (1762); Unspecified Infection (1930)
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Event Date 03/15/2017 |
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.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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Event Description
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Patient was revised to address an infection.
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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 received 3/28/17.Clinical report was received stating that patient was revised to address a periprosthetic joint infection.**update received 3/29/17.Clinical report was received stating that the patient suffered from a cardiac arrest resulting in death, relating to the procedure.
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Manufacturer Narrative
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No device associated with this report was received for examination.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.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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Search Alerts/Recalls
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