Medical records ad 23 feb 2021 were reviewed.On (b)(6) 2017, the patient had a right total knee replacement to address right knee osteoarthritis.Depuy components, including depuy patella, and depuy cement x2 were used during the procedure.On (b)(6) 2019, the patient had a revision of all components to address pain, decreasing motion, and tibial tray loosening.The tibial tray was noted to be loose at the cement/implant interface.Competitor components were used during this procedure.Doi: (b)(6) 2017; dor: (b)(6) 2019; (right knee).
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : device history reviewed: 3x unrelated non-conformances on this lot number.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional reports related to implant loosening.Total for lot number: 2 (b)(4).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 61.By product family: 192 (66x smartset ghv, 126x smartset gmv).
|