Device Problem
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.Please reference literature at the following location: http://www.Boneandjoint.Org.Uk/content/jbjsbr/93-b/8/1045.Full.Pdf (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 one patient underwent total hip revision arthroplasty due to massive subsidence of the stem.
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Manufacturer Narrative
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No device or photos were received; therefore the condition of the device is unknown.The lot number of the cpt stem is unknown; therefore the device history records, complaint history could not be reviewed.The reported device is used for treatment.It could not be confirmed if the device was 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.The cpt stem was implanted in the patient via a transgluteal lateral approach.Relevant medical history and adherence to rehabilitation protocol are unknown.A definitive root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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