Model Number NN911Z |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with as columbus cr narrow femur.According to the complaint description, the implant itself as well as the product label is discoloured and does not correspond to the standard.Discovery was not during goods receipt or in operation.There was no described patient harm.Another implant of the same size was available.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
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Search Alerts/Recalls
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