Catalog Number 150410208 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Synovitis (2094); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
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Event Date 03/06/2022 |
Event Type
Injury
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Event Description
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On (b)(6) 2017, the patient underwent a right total knee arthroplasty utilizing depuy synthes implants including patella and cement x 1.On (b)(6) 2022, the patient underwent a right knee revision secondary to pain, joint instability and suspected tibial tray loosening.Intraoperatively, scar tissue and synovitis was identified.The tibial tray was loose at the implant to cement interface.There was bone loss noted on the posterior aspect of the femoral condyles.All components were removed and revised to a competitor construct with exception of the patella that remained in situ.(b)(6) 2017 doi.(b)(6) 2022 dor (right knee).
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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.
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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 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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