Catalog Number UNK HIP ACETABULAR LINER POLY |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Anxiety (2328); Discomfort (2330); Unspecified Tissue Injury (4559)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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Plaintiff fact sheet and medical record received.Patient alleges that after the revision patient had experienced pain, stiffness, and soreness in the right hip area, metal staining throughout the tissue and had a pseudotumor formation in the posterior and inferior capsular areas that required removal, and pelvic bone deteriorated.Patient had anxiety, fear, and metallosis.Doi: (b)(6) 2021 - dor: unknown (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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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Search Alerts/Recalls
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