Catalog Number 136532000 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Swelling/ Edema (4577)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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Clinical adverse event received for revision; altr.Event is serious and is considered severe.Event is possibly related to device.Event is not related to procedure.Date of implant: (b)(6) 2006; date of revision: (b)(6) 2023; date of event: (b)(6) 2023; (right hip).Treatment: revision; head and liner were revised.
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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.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 the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:.
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Event Description
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Medical record received.On (b)(6) 2023, the patient had a revision right total hip to address pain, swelling, and bearing wear.The patient was noted to have had a previous metal on metal hip arthroplasty completed on (b)(6) 2006.During the current revision the surgeon observed blue-black synovial fluid, compatible with metallosis.The surgeon also noted an anterosuperior cyst which was debrided.There was considerable backside synovial foreign body metallosis reaction noted.Metal head and liner were removed and replaced with ceramic head and poly liner.Depuy components were implanted during this procedure.
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Search Alerts/Recalls
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