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Catalog Number UNK HIP ACETABULAR CUP |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problems
Tissue Damage (2104); No Code Available (3191)
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Event Date 09/30/2011 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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After review of medical records, patient was revised to address failed right hip replacement.Revision notes reported a dislodge polyethylene liner.A broken poly liner as well as a broken well-fixed shell and a well-fixed full coat stem in appropriate version and frozen section was negative for acute inflammation.It was noted that the acetabular shell itself was broken on the anterior aspect of it.A significant amunt of metallosis was also noted.Doi: (b)(6) 2009 - dor: (b)(6) 2011, (right hip).
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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. .
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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 lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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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