Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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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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(b)(4).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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Event Description
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On 28-jan-2019: ¿cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial¿ was reviewed for mdr reportability.The study followed 62 patients that were divided into two groups.Group 1: c-stem, ogee cup, and 28mm femoral head.Unknown cement was used.Three patients were reported to have died before discharge.One patient died during the process of cementing.No information was provided about the other two deaths.There is no indication the products caused or contributed to the deaths.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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