On 05 january 2024, b.Steinkamp (an onkos distributor) reported that a 77-year-old male patient who had allegedly suffered from instability in the knee joint involving a previously implanted eleos hinge knee replacement, underwent a revision surgery to replace the 10mm tibial poly spacer with a 20mm tibial poly spacer.The following eleos implants were also replaced as part of this revision: tibial hinge w/ rotational stop and resurfacing femur axial pin.The revision surgery was performed by dr.(b)(6).
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On 05 january 2024, b.Steinkamp (an onkos distributor) reported that a 77-year-old male patient who had allegedly suffered from instability in the knee joint involving a previously implanted eleos hinge knee replacement, underwent a revision surgery to replace the 10mm tibial poly spacer with a 20mm tibial poly spacer.All inspection and manufacturing data was reviewed for the 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 this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the knee joint instability was not related to the design, manufacture, and/or sterilization of the revised eleos implants.
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