DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Catalog Number 523418 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
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Event Date 03/18/2024 |
Event Type
Injury
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Event Description
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Patient was revised due to a nickel allergy.Pinnacle liner, srom metal head, and srom stem were revised.Patient was experiencing pain and swelling.Primary surgery done 1 year prior.Doi: (b)(6) 2023.Dor: (b)(6) 2024.Affected side: unknown hip.
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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 (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).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 523418/lot b0122t combination.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 search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 523418/lot b0122t combination.
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Event Description
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Additional information was received: -there was a surgical delay in that the case had to be preformed in order to remove these items and reimplant.-the adverse consequences to the patient is that they had to undergo revision surgery in less than 2 years after the initial surgery.
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Search Alerts/Recalls
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