Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Death (1802)
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Event Type
Death
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Manufacturer Narrative
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The complaint number corresponding to this medwatch is (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02025 & 0001825034-2017-02026.
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Event Description
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Information was received based on review of a journal article titled, "is there a benefit to modularity in ¿simpler¿ femoral revisions? ".It was reported that an unknown number of patients with monoblock femoral component died within 2 years post operatively due to unknown reasons.Attempts have been made, but no more information is available at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001822565-2017-03076.
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Search Alerts/Recalls
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