Catalog Number UNK HIP ACETABULAR CUP PINNACL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Distress (2329); Deformity/ Disfigurement (2360); Osteolysis (2377); Physical Asymmetry (4573); Swelling/ Edema (4577)
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Event Date 05/03/2021 |
Event Type
Injury
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Event Description
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Pinnacle litigation record received.Litigation alleges pain, mental anguish, disfigurement and emotional distress.Doi: (b)(6) 2008.Dor: may 3, 2021.Left hip first revision.
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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).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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Event Description
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Medical records received.After review of the medical records, the patient was revised to address propionibacterium infection, pain, hip fluid collection, aspirated fluid showed blood and propionibacterium, x-rays reported progressive lytic changes around the cup and stem.Operative note reported 20 ml of dark brown fluids with debris in the posterior hip, pseudotumor, thick fluid adherent to the trochanter, hip stiffness, heterotopic ossification, severe debris and discoloration of the cup with large lytics.There was large cystic changes around the acetabular cup and brown discolored tissue throughout the abductor bursa and the joint.Leg length discrepancy prior to surgery.
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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.H10 additional narrative: added: a2 (age, dob), a3, b5, b7, h6 health effect - clinical code.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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