Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Migration (4003)
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Patient Problems
Bone Fracture(s) (1870); 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 7 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 2: duraloc cup augmented with screws, corail or summit stem, 28mm femoral head, and polyethylene liner.The following adverse events were noted.Group 1 will be covered on (b)(4) and group 2 will be covered on a linked pc.Group 2: two patients experienced intra-operative fractures (unknown location stem or cup); one patient experienced an intra-operative fracture of the femur that resulted in a revision with subsidence noted.Four patients experienced non-fatal systemic complications (dvt, renal failure, mi, and pulmonary infection).
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Manufacturer Narrative
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Product complaint # (b)(4).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.Additional narrative: 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.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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