Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 10/12/2016 |
Event Type
Injury
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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.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
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Event Description
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Litigation alleges pain, discomfort, soreness, negatively affecting ability to perform activities of daily living.Ppf alleges loosening of stem, metal wear and metallosis.Doi: (b)(6) 2011 - dor: (b)(6) 2016 (left hip).
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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. .
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Event Description
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Pfs alleges leg length discrepancy.After review of medical records, operative notes indicates osteolysis.
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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.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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