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Catalog Number 313-35-00 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 09/08/2014 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery (b)(6) 2014.Revision due to glenoid side pain.
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Event Description
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It was reported by the patient that a "reem and run operation" on (b)(6) 2014.The patient stated "the cap was mislabeled for size.Due to imobility and pain, it was removed in (b)(6) 2015 and replaced with a full shoulder replacement." associated mfrs: 1038671-2017-00335, 1038671-2017-00336, 1038671-2017-00337.
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Manufacturer Narrative
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Associated mfrs: 1038671-2017-00335, 1038671-2017-00336, 1038671-2017-00337.Conclusion code: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The event of pain/discomfort is greater than 3 months postop and it is highly unlikely to be related to the surgical procedure or devices.The most likely cause of the reported event is related to the underlying patient condition.This device is for treatment, not diagnosis.
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Search Alerts/Recalls
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