Device Problem
Naturally Worn (2988)
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Patient Problem
Pain (1994)
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Event Date 07/26/2017 |
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 device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2007.Revision of right shoulder components due to glenoid wear and pain.The case report form indicates this event is unlikely 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 device was 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 wear of the natural glenoid bone 10 years after a hemi arthroplasty, which led to pain.The surgeon stated the event was "unlikely related" to the devices.
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Event Description
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Index surgery: (b)(6) 2007.Revision of right shoulder components due to glenoid wear and pain.The case report form indicates this event is unlikely related to devices.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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