Device Problems
Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
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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.Jshoulderelbow.Org/article/s1058-2746(12)00182-6/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 that superior migration of the humeral head consistent with superior subluxation was noted radiographically for 14 patients.
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Manufacturer Narrative
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No devices or photos were received; therefore the condition of the components is unknown.Device history records cannot be reviewed since the part and lot numbers are unknown.These devices are 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.Product history search cannot be completed and compatibly cannot be verified since the part and lot numbers are unknown.Patient¿s adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.
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Search Alerts/Recalls
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