Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 02/12/2014 |
Event Type
Injury
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Event Description
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It was reported patient underwent total shoulder arthroplasty on an unknown date.Subsequently, patient underwent revision on (b)(6) 2014 to replace components.
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date - unknown; date implanted - unknown; pma/510(k) number - unknown; manufacture date - unknown.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported patient underwent a total shoulder arthroplasty on an unknown date.Subsequently, patient was revised on (b)(6) 2014 due to pain.
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Search Alerts/Recalls
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