Catalog Number UNK HIP FEMORAL STEM SUMMIT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Osteolysis (2377); Metal Related Pathology (4530); Physical Asymmetry (4573)
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Event Date 05/02/2022 |
Event Type
Injury
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Event Description
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Asr litigation complaint received ad 7 dec 2022.Patient was revised was due to pain, discomfort, increase metal levels in blood including cobalt and chromium, injuries, emotional distress, disability, disfigurement, and economic damages.Doi: (b)(6) 2006.Dor: (b)(6) 2022.Right hip.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Plaintiff preliminary disclosure form and medical record received.The patient experienced osteolysis with greater than 50% of bone resorption at the acetabular interface with concern for loosening of the acetabular component and a slight limb length discrepancy was noted.
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Event Description
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On (b)(6) 2010, an orthopedic evaluation reported that the patient spent time to discussed his case, and report stated that left side was absolutely perfect, however on his right side still has problems with severe pain during 2 episodes during summer when going hiking afterwards flexis his hip a lot.On (b)(6) 2022, an operative reported that patient complained of right hip pain.X-rays obtained in clinic and show significant osteolysis with concern for loosening of the acetabular component.Patient undergone revision right total hip arthroplasty, acetabular component due to failed right total hip arthroplasty, metallosis and right hip osteolysis.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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