(b)(4).Reference: almazan a, herrera jp, chaidez c, cruz f, perez f, ibarra c.A complication of soft tissue graft tibial fixation with the intrafix device.Med sci monit.2009 jan;15(1):cs19-21.(b)(6).Patient characteristics: age: 43; gender: male; index operation: aclr (hamstring graft), chronic tear; devices: rigidfix + peek intrafix before 8 wks.Time of complication: before 8 wks.Type of complication: femoral tunnel screw divergence and migration.Joint: knee.Device: peek intrafix.Suture: na.Other devices: na.Signs and symptoms: progressive loss of extension: 10 degree vs.0 degree post-op, pain, crepitus in the antero-medial aspect of right knee (knee was stable) tissue damage: healthy looking acl graft which was impinged by fibrous tissue, tip of intrafix in the medial tibia plateau (mtp), implant was outside the original tibial tunnel and created a false way, 1.5x1.5 cm grade iii chondral injury on the lateral aspect of the medial femoral condyle (mfc).Imaging studies: x-ray: adequate tunnel position and no other finding.Reoperation (related/unrelated): excision of screw with forceps.Medical treatment: antibiotics (but no infection).F/u time: 1 wk.Imaging studies: na.Objective outcomes: wound healed, no infection.Functional outcomes: na.Subjective outcomes: na.
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Mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated.It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article.At this point in time, no further action is warranted.However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.Mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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