Catalog Number UNK HIP ACETABULAR METAL HEMI |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Metal Related Pathology (4530)
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Event Date 01/01/2024 |
Event Type
Injury
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Event Description
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It was reported that patient had an infected bilateral hip replacement.The patient also underwent 3 surgeries.Doi: unknown.Dor: unknown.Affected side: left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.Additional event information: bilateral hip replacement 2008 and right side replaced in 2016.Patient is experiencing pain and labs show high metal levels.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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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: added: b5 and 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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Additional information was received stating that they found horrible destruction from the metal poisoning.The two metals exceeded way above normal in blood tests.Tumor size of a juice jar of metal poison.
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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.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 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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