Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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Information was received via published literature.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pubmed/26920964.(b)(4).Other device used: catalog #unk, unknown coonrad/morrey ulnar assembly, lot #unk.This report will be amended when our investigation is complete.
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Event Description
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It is reported that one patient underwent a two-stage revision due to infection.
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Manufacturer Narrative
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There was no product returned; therefore, no physical evaluation could be conducted.The device history records could not be reviewed due to lack of product identification; the lot number required for retrieval was unavailable.This device is used for treatment.The investigation could not identify or verify any evidence of product contribution to the reported problem.This complaint could not be confirmed.Based on the available information, the need for corrective action is not indicated.
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Manufacturer Narrative
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Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.
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Search Alerts/Recalls
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