Catalog Number 32810508302 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/04/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported that a patient was revised due to infection.
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Manufacturer Narrative
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No devices or photos were received; therefore the condition of the components is unknown.Review if the device history records did not find any deviations or anomalies.These devices are used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search revealed no additional complaints against the related part and lot combinations.Patient¿s adherence to rehabilitation protocol is unknown.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 or contributed to any patient infection.A definite root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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