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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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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Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: yabuuchi k, et al.(2020), clinical outcomes and complications during and after medial open-wedge high tibial osteotomy using a locking plate, the orthopedic journal of sports medicine, volume 8, page 1-12, ((b)(6)) the purpose of this prospective study was to clarify the midterm (3-7 year) follow-up results after medial open-wedge high tibial osteotomy using the tomofix as well as major and minor complications found throughout the follow-up period.Between january 2009 and july 2013, 80 patients (85 knees) were included in the study.There were 66 women and 14 men with a mean age of 61.5 years at the time of surgery.All patients underwent fixation with a locking plate (tomofix) by insertion of (8) unknown synthes locking screws.The tomofix medial high tibia plate and the small tomofix medial high tibia plate were used in this study.Postoperatively, straight-leg raising and quadriceps sitting exercises, as well as active and passive knee motion exercises, were encouraged on the day after surgery.Partial weight-bearing was permitted with crutches 2 weeks after surgery.Full weight-bearing was allowed 4 weeks after surgery.Each patient underwent an additional procedure approximately 1 year (mean, 13 months; range, 7-30 months) after the initial surgery to remove the implanted tomofix because patients wanted the metal plate removed for religious reasons.Complications were reported as follows: minor (class 1): no additional treatment required 14 knees had lateral hinge fractures type i intraoperatively.Major (class 2): adverse events requiring additional or extended nonoperative management 1 knee had lateral hinge fractures type ii intraoperatively.4 knees had lateral hinge fractures type ii intraoperatively.1 knee had a superficial infection around the skin incision.7 knees had implant failure.3 knees had 1 or 2 broken proximal locking screw.4 knees had distal locking screw breakage.Major (class 3): additional surgery or long-term nonoperative treatment required 1 knee had an unacceptable overcorrection with a femorotibial angle of 162 degrees.A revision open-wedge high tibial osteotomy was performed 1 week after the first surgery.1 knee had nonunion in which 3 of the proximal locking screws had broken.A revision open-wedge high tibial osteotomy and iliac bone graft were performed by the use of bilateral plate fixation after 6 months 2 knees had a correction loss greater than 5 degrees and increased posterior tibial slope (more than 10 degrees).Total knee arthroplasty was performed 8 and 11 months after surgery 1 knee had a superficial infection requiring surgery.1 knee had implant failure: distal locking screw breakage (with tibial fracture) other complications: 9 knees had difficulty with inserted screw during hardware removal.In 5 knees, 7 screws inserted into the distal tibia were so tightly locked to the plate that we could not turn the screw head.In these cases, after we destroyed the screw head with a carbide-alloy drill, we detached the plate from the screws and then removed the inserted screw by hollowing out the bone tissue.In 1 of the 7 knees, a crack occurred in the tibial cortex during the hollowing procedure.23 knees had increased tibial length greater than 10 mm.32 patients had patella baja.10 knees were graded as fair knee function.3 knees were graded as poor knee function and underwent total knee arthroplasty at 8, 11, and 23 months after surgery because of residual knee pain in 1 knee and unexpected deformity of the proximal tibia in 2 knees.Unknown patients had postoperative pain.Mean knee injury and osteoarthritis outcome score (koos) was 81.4 (range, 57 to 100).17 knees had grade 3 osteoarthritis at the final follow-up.59 knees had grade 4 osteoarthritis at the final follow-up.9 knees had grade 5 osteoarthritis at the final follow-up.This report is for the tomofix medial high tibia plate, small tomofix medial high tibia plate, and unknown synthes locking screws.A copy of the literature article is being submitted with this medwatch.This is report 2 of 9 (b)(4).
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