Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 03/28/2022 |
Event Type
Injury
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Event Description
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Pinnacle mom litigation record received.Patient alleges elevated metal ion, significant wear from the metal-on-metal joint, and revising surgeon encountered milky fluid and trunnionosis type material on the trunnion which evidences metallossis and suffered injuries, including but not limited to significant pain, tissue destruction, bone destruction, and metal wear.As a direct and proximate result of the defective pinnacle, patient experienced emotional trauma and distress and is likely to experience emotional trauma and distress in the future and incurred lost of earnings.Doi: (b)(6) 2009.Dor: (b)(6) 2022.(left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).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.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.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.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).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.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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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.H6 clinical symptoms code: unspecified tissue injury (e2015) was 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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Event Description
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After a review of medical records patient was revised due to failed left hip replacement.Operative notes indicated adverse local tissue reaction, a cloudy joint fluid.The patient is concerned about the possibility of heavy metal poisoning.She had a hip replacement done and some of her follow-up tests looking at cobalt and chromium showed a very high level.She is not having her hip replacement taken out and read done.However, she still would like to have these levels checked to make sure they have come back down into the normal range.Implanted parts during the revision are still unknown.
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Search Alerts/Recalls
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