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 1 ¿ 87-year-old male patient implanted with sigma tc3 knee.Following placement he experienced pain.Synovial ions were notable for a co level of 30 mg/l and cr level of 1.3 mg/l.The diagnosis of taper corrosion of the femoral side of his tka was presumed, and he subsequently underwent a femoral revision.The femoral offset adapter and locking bolt were intact, without fracture or loosening.Intraoperatively, the female bore of the metaphyseal sleeve had geometric mechanical etches/scoring with associated corrosion debris.The male taper of the femoral component demonstrated a ring of wear and mild corrosion debris (figure 3 and 4).
|
Product complaint # (b)(4).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.
|