Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Hip Fracture (2349)
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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.
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Event Description
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It is reported that 2 hips suffered an intraoperative femoral fracture and developed progressive femoral subsidence.
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Manufacturer Narrative
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No devices or photos were received; therefore the condition of the devices is unknown.The part and lot number of the products are unknown.The reported devices are used for treatment.It could not be confirmed if the devices were used in an approved and compatible combination.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history is unknown.A definitive root cause cannot be determined with the information provided.
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Manufacturer Narrative
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Upon further investigation, it was found that with the information provided, the intraoperative femur fractures are a likely cause for the loosening as noted in the journal article.The root cause for the femur fractures cannot be determined with the information provided.
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Search Alerts/Recalls
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