Catalog Number 960054 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Joint Laxity (4526); Unspecified Tissue Injury (4559)
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Event Date 01/25/2024 |
Event Type
Injury
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Event Description
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Hcp sent a medical info request to team: "i have a patient in the clinic who has developed symptoms since several weeks after implantation of a pfc modular plus prosthesis.Surgical date (b)(6) 2008: pfc modular right knee: femur cemented, size 4, tibia cemented, size 3, plateau height 10 mm stabilized; patellum shaping.The patient now presents and the images show the inlay as worn/defective with a defect on the dorsal medial tibial console and ventral subluxation of the tibia to the femur.It is clear that there will be a certain amount of metallosis with a dorsally rubbed tibial component.As the manufacturer, is it still permissible to change the inlay alone in the case of a dorsally impaired tibial component?".
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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.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.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.No allegation against patella.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: according to the information received, "hcp sent a medical info request to team: "i have a patient in the clinic who has developed symptoms since several weeks after implantation of a pfc modular plus prosthesis.Surgical date (b)(6) 2008: pfc modular right knee: femur cemented, size 4, tibia cemented, size 3, plateau height 10 mm stabilized; patellum shaping.The patient now presents and the images show the inlay as worn/defective with a defect on the dorsal medial tibial console and ventral subluxation of the tibia to the femur.It is clear that there will be a certain amount of metallosis with a dorsally rubbed tibial component.As the manufacturer, is it still permissible to change the inlay alone in the case of a dorsally impaired tibial component?"".The product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4) x-rays).The x-ray investigation revealed nothing indicative of a device nonconformance.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the pfc*sigma c/s npor fem rt sz 4 would not contribute to the reported adverse event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 23-oct-2007.3) any anomalies or deviations identified in dhr: no.4) expiry date: 5/2/2014.5) ifu reference: ifu-0902-00-252.
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Search Alerts/Recalls
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