This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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This report is being filed after the review of the following journal article: metcalfe, a., et al.(2008) "spontaneous locking of the knee after anterior cruciate ligament reconstruction as a result of a broken tibial fixation device", arthroscopy: the journal of arthroscopic and related surgery, vol.24, no.10, pages 1195-1197 (united kingdom).This study emphasizes on a case report of intra-articular migration of a broken fixation device causing subacute mechanical symptoms in a man with a successful acl reconstruction.The patients evaluated on course of this study: a patient presented to the clinic complaining of frequent symptoms of knee instability after a motocross injury.An acute acl rupture was suspected and subsequently confirmed on magnetic resonance imaging.They presented a case of failure and intra-articular migration of the sleeve of an intrafix device causing locking of the knee 10 weeks after anterior cruciate ligament reconstruction.Rehabilitation had been progressing normally and without incident.The broken fragments were removed arthroscopically, and the reconstruction was found to be intact and healing well.The article describes the following procedure: spontaneous locking of the knee after anterior cruciate ligament reconstruction.The devices involved were: bioabsorbable rigidfix cross pins (depuy mitek) on the femoral side and an intrafix device (depuy mitek) in the tibial tunnel.Complications mentioned in the article were: - unfortunately, at 10 weeks postoperatively, he presented to the emergency department with a painful knee.Examination revealed a locked knee with 20° of flexion and acute effusion.- fragments that amounted to the whole of the intrafix expansion sheath were found and removed.
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