Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint (b)(4).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. h10 additional narrative: added: a2, b5, d2b, d4 (lot, catalog, expiration date, udi), d11, g5, h4, h6 (no code available (3191) is used to capture the surgical intervention and medical device removal) corrected: a1, b3, d1, d2.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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Medical records received on 14 jan 2020 were reviewed to identify patient harms/product issues on 27 jan 2020.The patient underwent a left knee revision due to pain and tibial tray loosening at the cement to implant interface.The femoral and patellar components were retained.The surgeon noted excising scar tissue aroung the patella, patellar tendon, quadriceps tendon, back of knee, and suprapatellar pouch and gutters.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2017 dor: (b)(6) 2018 left knee.
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