Batch review performed on 09 september 2022.Lot 181575: (b)(4) items manufactured and released on 28-june-2018.Expiration date: 2023-06-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director: approximately 6 months after implantation of a constrained tka, the radiographic control shows a broken insert screw.According to report, the patient reports pain, but it is not clear how and if such pain is related to the broken screw: the xray image, of very poor quality, shows radiolucency in the tibia near the implant, which in our opinion is a more probable cause of pain that will likely require revision.The size of the wedges under the tibial plateau is possibly too small, and there may be insufficient cortical contact.No xray history was supplied to try to understand when the fracture of the screw took place, therefore we cannot determine the causes for the adverse event.Most probably, the tibial component needs to be revised independently from the fractured screw.
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