The following information was reported and recorded under arthrex reference (b)(6).It was reported by a patient's attorney that the patient underwent an acl reconstruction procedure on (b)(6) 2016.Reporter disclosed that post-operatively the first reconstruction (initial surgery) had failed and an acl revision procedure (second surgery) was performed.The revision performed in the second procedure was also reported to have failed and a third surgery took place.During the third procedure the acl graft and hardware was found to be lax and a pin was malpositioned.The initial report did not specify the facility locations of each procedure or the procedure dates for the second and third surgery.No specific arthrex product numbers were provided in the initial report to confirm arthrex product involvement.The name of surgeon for third surgery was also not provided in initial report.Additional information obtained 7/10/18: initial surgery op report (b)(6) 2016: a right knee acl reconstruction was performed using tibialis anterior allograft; posterior horn medial meniscus repair was attempted and did not work so a partial lateral meniscectomy was done.During this procedure several manufactures product were used, with one of those being an arthrex tightrope.The specific arthrex part number was not indicated in the operative report.After review of the operative report by an arthrex product manager it was determined on 7/11/18 that the most likely part number for the acl tightrope used was the tightrope rt (ar-1588rt).Revision op report (b)(6) 2016: at the patient¿s first postoperative appointment it was determined the femoral fixation had failed and the tightrope was in the canal and the patient underwent a revision procedure at the same facility as the initial procedure by the same surgeon.The surgeon located the tightrope with a c-arm and found that the tightrope was stuck in the femur and stated there was no need to remove it.A graft was then placed on the tightrope and advanced through the femur anteriorly.Additional information obtained 7/10/18 recorded as arthrex reference number (b)(4): second revision op report (b)(6) 2017: after the (b)(6) 2016 revision surgery the patient developed quite a bit of stiffness.A workup including an mri demonstrated laxity of the acl graft as well as additional meniscal tearing.The patient underwent a second revision surgery on (b)(6) 2017 at a different facility performed by a different surgeon.During the surgery the graft was indicated to be grossly lax, with failure to hold any stability to the knee.Op report noted a meniscal repair had been attempted but the button was really not flipped on the capsule on the articular side contributing to additional cartilage loss at the femur.The surgeon removed the remnants of the acl graft, unstable portions of the meniscal tear as well as the tightrope button that was articulating with the cartilage.It was noted patient was 31 at time of (b)(6) 2017 procedure.
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