Catalog Number 545050501 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994); Joint Laxity (4526)
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Event Date 03/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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.Dmf# - 13704.Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements.
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Event Description
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Patient received a left total knee arthroplasty with a femoral autologous bone grafting on (b)(6) 2017 to address pain, and psoriatic arthritis.On 06 mar 2023, left knee was revised to address pain, recurrent patient falls and left knee instability, with replacement of tibial and femoral components to competitor system.The primary patella component tracked well and was retained.Doi: (b)(6) 2017.Dor: mar 06, 2023.Left knee.
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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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.
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Search Alerts/Recalls
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