Catalog Number 136553000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 05/12/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Pinnacle metal on metal hip medical records received.After review of the medical records the patient was revised to address metallosis, right hip pain, elevated cobalt and chromium level and large pseudocyst.Operative note reported debriding of soft tissues that showed significant metallosis.Note significant debris along the deep portions of the capsule.Lab result shows cobalt and chromium level were above 7 ppb.(b)(6).
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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 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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Search Alerts/Recalls
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