This report is for an unknown tomofix construct/unknown lot.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.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.
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This report is being filed after the review of the following journal article: kameda t., (2020) changes in the contact stress distribution pattern of the patellofemoral joint after medial open-wedge high tibial osteotomy.An evaluation using computed tomography osteoabsorptiometry, the orthopaedic journal of sports medicine, volume 9(4), pages 1-7 (japan) doi: 10.1177/2325967121998050.This study aims to determine whether there were any changes in the stress distribution of subchondral bone density across the pf joint before and after owhto in using ct osteoabsorptiometry.Between september 2013 and september 2015, patients who underwent owhto using locking plates (tomofix [depuy synthes] or a tris medial hto plate system [olympus terumo biomaterials]) were involved in this study.Total of 18 patients (18 knees) were enrolled in this study.The patients were evaluated in the outpatient clinic for 1 year or more after surgery; 1 patient did not complete follow-up.Thus, a total of 17 patients with 5 males and 12 females with mean age of 58.4 ± 9.4 (40-68) years (17 knees) participated in this study and underwent ct and radiologic evaluations.During surgery the tibia was fixed using a locking plate (tomofix or tris medial hto plate system) by inserting 8 locking screws.Patients were followed up at 14.4 ± 3.4 (12-23) months.The following complications were reported as follows: significant oa progression was found in 4 knees (24%) at the final follow-up.The tilting angle of the patella significantly changed from 8.6_ to 4.8_ (p <.0001 for both).Decreases in patellar height, potentially leads to akp, crepitus, extension lag, and decreased range of motion.Lower patellar height potentially increases the load of the pf joint, resulting in pf oa and akp.Degradation of the pf cartilage after owhto.This report is for an unknown synthes locking plate (tomofix construct).This is report 1 of 1 for (b)(4).
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