Catalog Number 999890249 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 02/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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.Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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Litigation record received.Asr depuy was implanted.Patient alleges injury, pain, suffering, emotional distress,economic loss, loss of services, loss of consortium, toxic cobalt and chromium metal ions and particles were released into plaintiff¿s blood, tissue and bone surrounding the implant and pseudotumors.Doi: (b)(6) 2008; dor: (b)(6) 2019 (left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).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 caused or contributed to the potential event described in this report.
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Manufacturer Narrative
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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.H10 additional narrative: udi: (b)(4).No code available (3191) used to capture the device revision or replacement product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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After review of medical records patient was revised to addressed failed left total hip arthroplasty with pseudotumor and metallosis.Operative notes indicated corrosion at the trunnion taper and minimal bone loss.Added medical history, age of patient, product details of cup, head, sleeve and stem.Also added srom sleeve in impacted products.Corrected patient's initial.Doi: (b)(6) 2008 dor: (b)(6) 2019 left hip.
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Search Alerts/Recalls
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