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Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Angina (1710); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Tissue Damage (2104); Respiratory Tract Infection (2420); No Code Available (3191)
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Event Type
Injury
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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.Pertains to 19 patients.
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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.One patient had an intra-operative fracture (unknown location stem or cup).One patient sustained a dislocation.One patient underwent a revision for a loose acetabular cup.Eleven patients experienced abductor dysfunction.One patient experienced ectopic ossification.Seven patients experienced non-fatal systemic complications (1 for dvt, pe, renal failure, mi, pulmonary infection and 2 for cardiac ischaemia).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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