Company was notified of a scheduled removal surgery following localized pain in the operated left foot a year after implantation.The removal surgery was completed successfully.An investigation was performed including internal analysis of records, patient imaging, lab work and surgeon feedback.There is no indication of a design, manufacturing, sterilization, or process issue affecting implant safety or effectiveness.There were no issues during the primary procedure.Patient post op recovery was uneventful, and bone healing and fusion of the operated sites was achieved.Imaging due to the reported pain revealed localized bone edema.Infection was ruled out by the lab work, negative culture, and timing of symptoms.The investigation concluded that the root cause of the pain could not be determined but is likely the outcome of the patient experiencing a local reaction to one of the implant's materials or related to an unreported underlying medical condition.Instructions for use list an allergic reaction as a potential adverse effect to implantation of foreign material.Company continues to monitor these events as part of post market activities.Additional reports relating to this event: # 3014554088-2024-00003/4/5 & 3014323288-2024-00003/4/5/6.
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