Author: lee (2011) south korea reference: lee kb, song sy, paik sh, shin wh.Delayed intra-articular migration of the intrafix outer sheath after anterior cruciate ligament reconstruction: a case report.Knee.2011 oct;18(5):347-9.(b)(6).Patient characteristics: age: (b)(6).Gender: female.Index operation: acl repair (8.5-mm tibialis allograft), partial menisectomy devices: bioabsorbable rigidfix and 9-mm non-absorbable intrafix (4 separate channels for graft) + post-tie staple time of complication: 5 mo.Type of complication: migration of the outer sheath into the joint joint: knee.Device: intrafix.Suture: na.Other devices: na.Signs and symptoms: 5 months: sudden catching sensation and slight pain with swelling exam: full range of motion and mild effusion, lachman test: 1+ with a solid endpoint, pivot test negative 6 months: moderate effusion, rom: 20° to 130°, lateral joint line tenderness.Tissue damage: labs showed no signs of infection.Reactive synovitis.Acl graft had a small portion of disruption but good incorporation.Sheath anchored to the intra-articulr opening of the tibial tunnel.Imaging studies: x-rays: no tunnel enlargement.Reoperation (related/unrelated): aspiration 60 cm3 of serous fluid, culture negative.Removal of intrafix sheath in several pieces.Debridement of disrupted graft fibers (<10%), synovectomy.Removal of intrafix screw through tibial cortex (related).Medical treatment: - na.F/u time: - na.Imaging studies: - na.Objective outcomes: - na.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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