Product complaint # (b)(4).Component code: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.A-7573439 - (b)(6) 2022.(b)(4) medical records ad (b)(6) 2022 was reviewed by a clinician on (b)(6) 2022.Primary operative notes of the left knee were provided that confirm doi is (b)(6) 2017.The left primary tka was performed successfully without complication.Competitor cement was utilized and the patella was resurfaced.This complaint will be updated with part/lot information, which is provided on page 31.Revision notes indicate that on (b)(6) 2020, the patient underwent a left knee revision.Notes indicate the patient underwent a previous left extension mechanism reconstruction in 2019.This will be captured on a linked pc.The patient continues to have pain "in the extensor lag on the lle" as well as gapping in the patient's quad area.She also continues to have extensor weakness so an extensor mechanism reconstruction using mesh was performed during the revision.Significant atrophy in the quad muscle was noted along with stretching of the last extension mechanism repair.Gray tissue noted along the tibial tray.Tray loosening was found at the implant to cement interface.Pmh includes left knee patellar tracking disorder on (b)(6) 2021 though no further information provided on any intervention received.This event will be captured on a linked pc as well.Operative notes involving the right knee are also included in this attachment, though (b)(4) (right knee) will be updated with this information.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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