Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 10/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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The der indicated an asr revision.Litigation alleges personal and injuries, elevated metal ion, severe pain, significant inhibitions of her ability to walk and move, and severe corrosion in left hip, anxiety, fear, mental anguish, depression, suffering, emotional distress, economic loss and other emotional and physical damages.Added stem due to elevated metal ion allegation.Doi: (b)(6) 2006 - dor: (b)(6) 2017, (left hip).
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Manufacturer Narrative
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Product complaint # = > pc-(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.H10 additional narrative: added:e1.
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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 : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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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