Batch review performed on 05 january 2023: lot: 124930ar: (b)(4) items manufactured and released on 04-mar-2014.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: 8 years after revision tka made using a constrained device, the screw that holds the femoral component to the metal post in the center of the tibia got loose.The quality of the images supplied is extremely poor and little can be extracted from them.However, the loosening of the screw,according to the report, did not create any damage to the artificial articulation and it was sufficient to tighten the screw again - of course, this implied one more surgery.The causes for unexpected unscrewing of the component may be of different kinds: the most probable one, reproduced in laboratory simulations, is insufficient tightening torque applied at index surgery.For this reason, a torque-limiting screwdriver is part of the instrument set.
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