Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Toxicity (2333)
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Event Type
Injury
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Event Description
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Patient reported to have undergone left shoulder arthroplasty on an unknown date in (b)(6) 2003.Subsequently, patient reported allegations of high nickel ions levels.No revision has been reported to date.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "material sensitivity reactions.".
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Manufacturer Narrative
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Corrected data: initial surgery was confirmed to have taken place on (b)(6) 2003.Date implanted - (b)(6) 2003.
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Event Description
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Patient reported to have undergone left shoulder arthroplasty on an unknown date in (b)(6) 2003.Patient further reports allegations of high nickel ions levels.No revision has been reported to date.A review of invoice history revealed that the initial shoulder arthroplasty took place on (b)(6) 2003.
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Search Alerts/Recalls
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