Catalog Number 101211088 |
Device Problems
Corroded (1131); Malposition of Device (2616)
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Patient Problems
Foreign Body Reaction (1868); No Code Available (3191)
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Event Date 04/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Unf and medical records received.There is no allegation reported from unf.After review of medical records, patient was revised to address, aseptic loosening right total hip arthroplasty acetabular component and metallosis.Revision note reported metallosis, metal debris, taper corrosion on trunnion, 10 degrees anteversion of stem, acetabular component grossly loose, implant fracture and bone loss.Doi: (b)(6) 2006; dor: (b)(6) 2017 (right hip) first revision.
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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.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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