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); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 07/11/2022 |
Event Type
Injury
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Event Description
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Pinnacle mom litigation record received.Litigation alleges heavy metal poisoning, injury to muscle and tissue, suffered additional scar tissue formation and now has a hip replacement with decreased longevity.Moreover.Suffered injuries, including but not limited to significant pain, injury caused by metallosis, metal wear, loss of enjoyment of life and limitation of daily activities.Patient incurred medical expenses and expects to incur additional expenses in the future.Additionally, has sustained emotional trauma and distress, mental anguish and economic losses.Doi: (b)(6) 2006, doe/dor: (b)(6) 2022, unk affected side (hip).
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Occupation: lawyer.(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.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).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: metal related pathology (e1618) used to capture metal poisoning and 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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Pinnacle mom medical record received.Medical records report closed reduction dislocation on (b)(6) 2022.Affected side: left hip.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: updated on 20 oct 2023.No device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (mre) will not be performed, since mom systems are obsolete.
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Event Description
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On (b)(6) 2022, an operative note of a femur fracture was treated with wires.The stem was retained.
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Search Alerts/Recalls
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