Catalog Number 121730500 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Foreign Body Reaction (1868); Necrosis (1971); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 12/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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(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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Ppf and medical records receive.Ppf alleged loosening of the cup, dislocation, and elevated metal ions.After review of the medical records, the patient was revised to address the loosening of acetabular component, soft tissue loss, metallosis, and dislocation.Operative note reported of massive soft tissue destruction and broken 2 screws.There was no lot number provided for the broken screws.Doi: (b)(6) 2012; dor: (b)(6) 2016; (right hip) fourth revision.(b)(4) (right hip) 1st revision; (b)(4) (right hip) 2nd revision; (b)(4) (right hip) 3rd 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.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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