Model Number 3L92510 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
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Event Date 12/05/2022 |
Event Type
Injury
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Event Description
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Litigation record received.Litigation record stated that on (b)(6) 2006, plaintiff had a metal on metal pinnacle system implanted.On (b)(6) 2022, patient was forced to go surgical removal of the defective pinnacle system of patient's hip at the houston methodist hospital in houston.The plaintiff suffered heavy metal poisoning from toxic heavy metals resulting injury and requiring surgery.As a result of surgical removal, plaintiff suffered injury to his muscle and tissue and suffered additional scar tissue formation and experienced significant pain, injury by metallosis, metal wear and metal poisoning.Doi: (b)(6) 2006; dor: (b)(6) 2022; unknown affected side.
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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.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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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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Search Alerts/Recalls
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