Batch review performed on 13 december 2022.Lot 2108899: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-aug-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation: few months after primary cemented tkr in a young female patient, instability is perceived while the implants are otherwise performing properly.Secondary instability is a possible adverse event following tkr and it's mainly due to disease progression.No reason to suspect a faulty device at the origin of this complaint.
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