Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problems
Degraded (1153); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Synovitis (2094); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).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 litigation records received.Litigation alleges pain, injury, pseudotumor, inflammation, tissue and bone loss, bone erosion, corrosion, friction and wear, elevated metal ions level.Extensive metallosis, trunnionosis and synovitis discovered during the revision surgery.Doi: (b)(6) 2005 dor: (b)(6) 2019 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.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 : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per (b)(4), it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.
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Search Alerts/Recalls
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