Catalog Number UNK KNEE TIBIAL TRAY SIGMA |
Device Problem
Corroded (1131)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 05/30/2023 |
Event Type
Injury
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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 4 ¿ 66-year-old male implanted with sigma tc3 in his right knee.He presented to our clinic 4 years later with recurrent pain in his r tka and a large soft tissue mass at the medial aspect of his knee.A punch biopsy was performed at an outside facility, which revealed benign fibrous material, and he continued to drain from this site for 2 weeks.Given his history of draining sinus over his medial knee mass, which was believed to communicate to the hardware via the tibial erosion, the decision was made to perform a 2-stage revision tka.At his stage one revision tka, the knee did not appear infected, and all cultures were ultimately negative.The mass was decompressed, and an articulating antibiotic spacer was placed.Corrosion debris was seen at the end of the tibial female bore (sleeve), near the site of the tibial bone erosion and adjacent mass that was consistent with a pseudotumor-like appearance.The femoral component also demonstrated corrosion at the femoral trunnion and sleeve the femoral offset adapter and locking bolt were intact, without fracture or loosening.Three months later, he was taken for stage 2 reimplant.
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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.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: ¿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.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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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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