Model Number 1365-55-000 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Fatigue (1849); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Dizziness (2194); Distress (2329); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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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Pinnacle poly on metal medical record received.After review of the medical records the patient was revised to address pain, difficulty with function mobility, metallosis, polyethylene wear, tear, trunnionosis and high level of metal ions in his blood.Operative note reported some fluid, black tissue that was removed.There was significant trunnionosis.Synovium was removed approx.30 minutes.Doi: (b)(6) 2011, dor: (b)(6) 2020 left 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.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.Device history lot = > per legacy complaint (b)(4), a previous device history record (dhr) review did not reveal any related manufacturing deviations or anomalies.H10 additional narrative: added: h6 clinical symptoms code: appropriate term/code not available (e2402) used to capture blood heavy metal increased.
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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: h6: appropriate term / code not available (e2402) is utilized to capture blood heavy metal increased.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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Litigation alleges pain, loss of balance, dizziness, difficulty walking, stomach upset, deterioration and failure of the product, elevated metal ions, abrasion of the metal on metal components with the bearing causing metal debris in the body, tissue dehiscence, necrosis, hypertrophic scarring, antalgia, lumbar strain, fatigue, limited adl and emotional distress.Doi: (b)(6) 2011; dor: (b)(6) 2020; unknown 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.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.Device history lot: per legacy complaint (b)(4), a previous device history record (dhr) review did not reveal any related manufacturing deviations or anomalies.
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Search Alerts/Recalls
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