Batch review performed on 19 december 2022: lot 182059: (b)(4) items manufactured and released on 26-june-2018.Expiration date: 2023-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Addtional component involved: gmk-hinge 02.09.He20 gmk-hinge hinge post extension 20 mm -tinbn coated (k210010) lot.2011024: (b)(4) items manufactured and released on 05-feb-2021.Expiration date: 2026-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
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The patient had a primary knee surgery on (b)(6) 2022.Subsequently, the patient came in reporting pain due to the knee incision opening up during physical therapy.On (b)(6) 2022, the surgeon performed a washout and swapped the poly.On (b)(6) 2022, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and post extension.The surgery was completed successfully.
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