Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Patient underwent a total knee revision as a result of loose femoral component and was revised to an attune revision knee prosthesis with femoral sleeve, stem and a tibial sleeve and stem.Attune revision size 8 femur with attune rp size 7 tibial tray and 6 mm poly insert were also used.Loosening of the femoral component was reported at an unknown interface.Cement manufacturer was unknown.There was no surgical delay.Doi: (b)(6) 2004, dor: (b)(6) 2022, affected side: right knee.
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