Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Fracture (1260); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Foreign Body In Patient (2687); No Code Available (3191)
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Event Date 11/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Patient: surgical intervention.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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Patient received hip-tep left side in another hospital in 2002.Revision on (b)(6) 2019 because fracture of biolox forte hip head and inlay.No surgical delay reported.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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.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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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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Search Alerts/Recalls
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