Catalog Number 999890147 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Death (1802); No Code Available (3191)
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Event Type
Death
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
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Event Description
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Asr claim record received.It was reported that the original claimant has died (date of death: (b)(6) 2015) and their estate is claiming the death was a caused by the revision surgery and/or medical condition consequent on the revision surgery.The cause of death has been asserted as pulmonary embolism (pe).Doi: (b)(6) 2007; dor: (b)(6) 2011; unknown hip.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Manufacturer Narrative
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Product complaint : (b)(4).Investigation summary : revision of the device has been reported and the allegations indicates the patient sustained a pe and death after the revision.At this time our devices cannot be excluded as a possible cause of the pe and death.No explanted devices have been received in respect of this patient for analysis.Manufacturing records have been reviewed and the device(s) met specification prior to placing on the market.If further information is received then this event will be re-opened for evaluation.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
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Search Alerts/Recalls
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