Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Rash (2033)
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Event Type
Injury
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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.Remains implanted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction.¿ this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 3 of 3 mdrs filed for the same event (reference 1825034-2015-04935 / 04936 / 04937).
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Event Description
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It was reported that patient underwent left total hip arthroplasty on (b)(6) 2006.Subsequently, patient is experiencing a reoccurring rash due to unknown causes.A metal allergy test is scheduled to occur.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.
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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 that patient underwent left total hip arthroplasty on (b)(6) 2006.Subsequently, patient is experiencing a reoccurring rash due to unknown causes.A metal allergy test is scheduled to occur.No further information has been provided.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.Additional information received reported the rash was confirmed as an allergic reaction; however, it is unknown if it a metal allergy.No revision procedure will be performed.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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