Catalog Number 320-46-10 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032)
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Event Date 10/20/2014 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2014.Revision of right shoulder components due to pain, decreased range of motion and signs of infection.The case report form indicates this event is not related to devices.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of a combination of the pain and decreased range of motion, likely caused by the reported fall, and infection, which is addressed in the product labeling under general surgical risks.
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Event Description
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Index surgery: (b)(6) 2014.Revision of right shoulder components due to pain, decreased range of motion and signs of infection.The case report form indicates this event is not related to devices.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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