Catalog Number 00584202508 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/03/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Information was received from a foreign source 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 is reported that a hair was on the articular surface when the implant was opened.A new implant was opened and used.
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Manufacturer Narrative
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This report is being amended to reflect changes.Visual inspection of the returned articular surface indicates device is in "like-new" condition.The original packaging was not returned for review as the product was returned in packaging from another device.The alleged hair is not present on the returned product or packaging.Device history records were reviewed and no deviations or anomalies were found.This device is used for treatment.A product history search revealed no additional complaints against the related part and lot combination.Zimmer implants are sterilized to meet fda regulations and iso standards at a sterility assurance level (sal) of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the presence of the foreign material found in the package would lead to any infections or other bio-incompatibility if the device had been used.The alleged event cannot be verified; a definitive root cause cannot be determined.
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Search Alerts/Recalls
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