The patient underwent a revision surgery on (b)(6) 2023 due to the patient's tibial hinge component dislocated from the tibial poly spacer.This is the 2nd revision surgery for this patient.During the 2nd revision surgery, the following eleos implants were revised: poly spacer.A review of the work order and sterilization batch release record for the product involved found no indication that the implant dislocation was a result of a manufacturing or sterilization nonconformance.The eleos complaint history record was reviewed, which found eight (8) previous complaints for tibial hinge dislocation.Therefore, a complaint trend was not identified.The root cause of the tibial hinge dislocation could not be determined.Based upon review of the device history records and sterilization records, the investigation concluded that the root cause of the tibial hinge component is most likely not related to the design, manufacturing, and/or sterilization of the component.
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