Device Problems
Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Information was received via published literature.(b)(4).This report will be amended when our investigation is complete.Please reference literature at the following location: http://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc3613521/.
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Event Description
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It is reported that progressive radiolucent lines about components and radiologic component loosening or migration was observed in 2 femurs.
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Manufacturer Narrative
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Device history records could not be reviewed as the part and lot numbers are unknown.This device is 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.A definitive root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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