Device Problem
Device Slipped (1584)
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Patient Problem
Fall (1848)
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Event Date 07/05/2017 |
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) 2009.Revision of left shoulder components due to loose humeral stem, likely due to glenoid wear after fall 8 weeks post-op.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 the patient's fall, which led to wear of the glenoid and eventual loosening of the humeral stem.Wear and loosening are addressed in the product labeling.
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Event Description
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Index surgery: (b)(6) 2009.Revision of left shoulder components due to loose humeral stem, likely due to glenoid wear after fall 8 weeks post-op.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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