Catalog Number 157001135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)
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Event Date 06/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # : (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Event Description
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Litigation records ad (b)(6) 2023 alleges pain and discomfort, increased metal levels in blood including cobalt and chromium- permanent injuries, emotional distress, disability, disfigurement, economic damages including medical and hospital expenses for revision surgery followed by monitoring , rehabilitation and pharmaceutical costs.Doi: (b)(6) 2009.Dor: (b)(6) 2022.Affected side: right hip.
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Event Description
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The patient underwent a two-stage hip revision in periprosthetic infection.
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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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Update: 27-july-2023.Update received on 21-july-2023, did not have any additional details to be added in investigation.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.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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Litigation and medical records received.Patient is uncertain when symptoms began.Sustained injuries to his tendons, ligaments, tissues and bones within his right hip.Suffered cold-like symptoms and breathing difficulties which turned into pneumonia.Doctors could not get his illness under control.Cobalt and chromium levels were elevated.Found metallosis throughout the hip and infection in hip joint.Post-revision surgery.Patient was hospitalized and had an infection.Needed to have pik line for the antibiotic to treat the infection.Uses 4-wheel walker or wheelchair to avoid fall.Has anxiety about all the damage the high ion levels and metal in the bloodstream.Patient had failed tha; metallosis; elevated cobalt & chromium levels and had his 1st revision on (b)(6) 2022 and patient had re-revision on (b)(6) 2022.( two stage revision for infection).
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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: b5, b7 and h6 clinical symptoms code: unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.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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