Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Seroma (2069); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 09/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.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 alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007.Dor: (b)(6) 2021.Affected side: unk.
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Event Description
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After a review of medical records, operative notes reported a large amount of fluid and blood, black-tinged stained tissue.There was a notable effusion and seroma evacuated through the peripheral area of the cup indicating a large defect on the posterior aspect and medial aspect of the cup.The cup was extracted and there was a severe bone loss.The affected side is the right hip.
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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: clinical symptoms code: metal related pathology (e1618) used to capture metal poisoning and blood heavy metal increased and 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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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.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.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).Investigation summary : litigation records alleges heavy metal poisoning from the toxic heavy metals released by the pinnacle system resulting in injury and requiring surgery to remove the defective hip replacements.Patient was consequently revised due to injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.Additionally, patient suffered pain , injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, incurred additional medical expenses, lost earning potential/ income, and ultimately emotional trauma and distress in the future.Doi: (b)(6) 2007, dor: (b)(6) 2021, affected side: unk.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).Visual inspection of the provided patient x-rays revealed there were no product problems observed with unk hip femoral head metal.After visual inspection the investigation did not find enough evidence to confirm the reported allegation.The overall complaint was unconfirmed as the observed condition of the unk hip femoral head metal would not contribute to the complained device issue.Based on the investigation findings it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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