Catalog Number UNK KNEE TIBIAL STEM |
Device Problem
Corroded (1131)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 05/30/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # :(b)(4).The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: article entitled ¿metallosis and corrosion associated with revision total knee arthroplasties with metaphyseal sleeves¿ written by joshua p.Rainey, md, jeremy m.Gililland, md, christopher l.Peters, md, michael j.Archibeck, md, lucas a.Anderson, md, and christopher e.Pelt, md published in arthroplasty d4-the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Article entitled ¿metallosis and corrosion associated with revision total knee arthroplasties with metaphyseal sleeves¿ written by joshua p.Rainey, md, jeremy m.Gililland, md, christopher l.Peters, md, michael j.Archibeck, md, lucas a.Anderson, md, and christopher e.Pelt, md published in arthroplasty on may 30, 2023 was reviewed.The aims of this study were to compare implant survivorship, perioperative factors, and clinical outcomes of dfr vs.Orif for comminuted distal femur fractures.Case 2 ¿ 64-year-old female patient implanted with bilateral sigma tc3 knees.At 1 year she began to experience pain in the right knee and then in the left knee.She experienced decreased rom.Both knees were revised.Right knee the femoral condylar segment was debonded from the surface cement mantle, though the femoral sleeve was well-fixed.The femoral offset adapter and locking bolt were intact, without fracture or loosening.Corrosion was noted at the femoral trunnion to sleeve bore interface.There was abundant scar and fibrotic tissue throughout the knee.Left knee revision - intraoperatively, there was similar abundant fibrotic tissue and evidence of corrosion debris, with significant corrosion at the tibial tray and sleeve interface.Interestingly, in the left knee, we found the proximal tibial tray to be loose with a well-fixed tibial sleeve.The femoral offset adapter and locking bolt were intact, without fracture or loosening.
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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.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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