The root cause of the dislocation of the tibial hinge component was unable to be determined.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture of the implants or a nonconformance.
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A (b)(6)-year-old male underwent a revision surgery of eleos components on (b)(6) 2020 performed by dr.(b)(6) due to the patient's tibial hinge component dislocating causing the lower leg to separate from the upper leg.The tibial augment that was placed during the primary surgery but was removed during the revision surgery and not replaced.A 20mm poly spacer was removed and replaced with an 8mm poly spacer.Bone was resected from the tibia and a 40mm midsection was placed.A 16mm x 100mm stem extension was removed and replaced with a 15mm x 100mm stem extension.The reason for the size change of the stem extension is not known.The segmental stem that was placed during the primary surgery was not explanted during the revision.The surgeon expected the implant during surgery and stated that it was not damaged.A distal femur axial pin, tibial hinge component, tibial baseplate, and distal femur components were explanted and replaced with identical components.
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