This report is a retrospective investigation regarding two of the three revision surgeries for a single patient that onkos was previously unaware.Refer to section 3.0 for additional information.During the first revision surgery on (b)(6) 2022, the originally implanted 8mm tibial poly spacer was replaced with a 12mm tibial poly spacer.During the second revision surgery on (b)(6) 2023, the 12mm tibial poly spacer was replaced with a 20mm tibial poly spacer.The patient received an eleos hinge knee replacement on (b)(6) 2022 at which time an 8mm tibial poly spacer was implanted.The surgeon for the primary surgery and the first two surgical revisions was performed by doctor siverhus.The third revision was performed by (b)(6).Additional patient history and surgical details were not able to be provided upon request to (b)(6).
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This report is a retrospective investigation regarding two of the three revision surgeries for a single patient that onkos was previously unaware.During the first revision surgery on (b)(6) 2022, the originally implanted 8mm tibial poly spacer was replaced with a 12mm tibial poly spacer.During the second revision surgery on (b)(6) 2023, the 12mm tibial poly spacer was replaced with a 20mm tibial poly spacer.All inspection and manufacturing data was reviewed for the known revised eleos implants; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that represent potential contributing factors to the adverse effect(s) identified in this complaint.The root cause of the historical adverse events associated with this retrospective complaint were not determined; however, the reported patient weight including excessive soft tissue surrounding the knee joint is likely to be significant contributing factor.Based on review of device history records, the investigation concluded that the root cause of the knee joint laxity and/or dislocation was not related to the design, manufacture, and/or sterilization of the known revised eleos implants.The following mdrs were submitted as part of this adverse event: 3013450937-2024-00050 (retrospective investigation; revision surgery #2) 3013450937-2024-00056( retrospective investigation, revision surgery #1).
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