On (b)(6), 2017, a patient underwent an initial subchondroplasty procedure.On (b)(6) 2019, zimmer knee creations became aware of the adverse event of osteoarthritis which resulted in a total knee replacement of the left knee that occurred on (b)(6) 2019.The health care professional assessed the event and determined it was possible related to the subchondroplasty study procedure and not related the accufill implant.The operative notes for the event were requested from the clinical project lead.The product was not returned for the investigation, as it remains implanted in the patient.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.Device remains implanted.
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Subject 20-0136 of the subchondroplasty observational knee study received an accufill implant during the index procedure on (b)(6) 2017.The pre-operative diagnosis was complex tears of the medial and lateral meniscus, chondromalacia, insufficiency fracture of the tibia, and insufficiency fracture of the femur, all of the left knee.Prior to the index procedure, the patient had undergone corticosteroid injections, viscosupplementation, and physical therapy and wore a double-hinged knee brace to attempt to address the pain.The preoperative diagnosis was confirmed during the index procedure.To address the insufficiency fractures, approximately 3cc¿s of accufill was injected into the distal femur, and approximately 3cc¿s of accufill were injected into the proximal tibia.In addition, a partial lateral meniscectomy, a partial medial meniscectomy, and abrasion arthroplasty of the medial femoral condyle were performed.Following the procedure, the patient awoke successfully from general anesthesia in stable condition.Following the index procedure, the patient experienced an adverse event of osteoarthritis, but the date of onset was not reported.The condition resulted in a total knee replacement of the right knee on 19 june 2019.The health care professional reported this event was possibly related to the subchondroplasty study procedure but not related the accufill implant.Although a definitive root cause cannot be determined, the event is most likely associated with the patient¿s osteoarthritic condition.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The device in question remains implanted in the patient and therefore was not returned for the investigation.There were no images available for review.
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