This file is a review of the following journal article: castelli, a., et al (2020) the role of the anterolateral ligament in knee¿s biomechanics: a case¿control retrospective study.European journal of orthopaedic surgery & traumatology, vol.30, pages 653-658 (italy).The study emphasizes on the assessment of the functional and clinical results of patients who underwent acl reconstruction surgery and were divided into subpopulations related to acl associated lesions and focused on all-associated lesion.The patients evaluated on course of this study: 62 patients.The article describes the following procedure: acl reconstruction surgery.The devices involved were: rigidfix and bio-intrafix.The overall re-injury rate in our cohort of patients was 4.8%.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Multiple attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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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