Catalog Number 201002350 |
Device Problems
Fitting Problem (2183); Device-Device Incompatibility (2919)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (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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It was reported that the actis trial necks keep sliding off broaches.They called r.O in hip marketing and told they have fixed this issue in the newer sets.Needing to get three sets of trial necks for actis standard and high offset.R.O told him to fill out mdr form and i cld get older style actis necks replaced.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 : examination of the returned instrument confirmed the complaint.The root cause is attributed to design.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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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.Added: device identification,concomitant medical products and device manufacture date.Corrected : device evaluated by mfr.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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