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 from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.
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Event Description
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It was reported that a patient underwent a two-stage revision for infection with the second stage occurring on (b)(6) 2015.
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Manufacturer Narrative
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Operative notes were requested however none provided.No devices or photos were received; therefore the condition of the components is unknown.The part and lot numbers of the product are unknown; therefore the device history records could not be reviewed.These products were used for treatment.The complaint history for these products could not be reviewed due to the lack of lot numbers.It could not be confirmed if the devices are an approved and compatible combination.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.A definitive root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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