Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 12/10/2014 |
Event Type
Injury
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Event Description
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It was reported patient underwent a total shoulder arthroplasty on an unknown date.Subsequently, the patient was revised on (b)(6) 2014 due to an unknown reason.
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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.Brand name.Product / lot code / expiration date.Date of implant.Pma/510(k) number.Manufacture date.
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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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Search Alerts/Recalls
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