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This report is for an unknown plate and screw construct/unknown lot.Part and lot number are unknown; udi 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.(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.(b)(4).
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This report is being filed after the review of the following journal article: terjesen t., (2019) femoral and pelvic osteotomies for severe hip displacement in nonambulatory children with cerebral palsy: a prospective population-based study of 31 patients with 7 years¿ follow-up, acta orthopaedica volume 90(6), pages 614-621 (norway).This prospective study aims to answer the following questions: what is the outcome of reconstructive hip osteotomies combined with soft-tissue releases in nonambulatory children? is there any difference in outcome between hips with combined femoral and pelvic osteotomies and hips with isolated femoral osteotomy? are there any predictors for good and poor outcome? is prophylactic femoral osteotomy of the contralateral non-subluxated hip indicated? during the period of 2007¿2014, a total of 31 children (20 boys and 11 girls) mean age at surgery was 6.1 years (2.2¿9.9) who had consecutively undergone 39 femoral and/or pelvic osteotomies (8 bilaterally) were recruited for this study.The osteotomy was fixed with a 110° pediatric locked compression plate (lcp; synthes, switzerland) (rutz and brunner 2010) in 30 osteotomies and a 90° ao blade plate in 2.In the remaining 7 osteotomies a straight plate with 2 screws in each fragment was used.The mean follow-up time of children who have not undergone subsequent hip surgery was 7.1 years (3.8¿11) and their mean age at the latest follow-up was 13.6 years (11.3¿16.6).The following complications were reported: 2 patients died (b)(6) and (b)(6) years, respectively, after the index operation.A case of an (b)(6) years, girl, with severe subluxation of her left hip 6 weeks after femoral and pelvic osteotomies of the left hip and bilateral soft tissue releases, showing good femoral head coverage.2.9 years postoperatively (age (b)(6) years), showing relapse of subluxation of her left hip.2 patients had subluxation with preoperative mp 48% and 51%, respectively, on the contralateral side, and these hips deteriorated postoperatively.A case of a (b)(6) year old girl with complete dislocation of her right hip (mp 100%) and subluxation of her left hip (mp 51%).14 months after femoral and pelvic osteotomies of the right hip and bilateral soft tissue releases, showing slight subluxation of both hips (mp right hip 36% and left hip 37%).7.3 years postoperatively (age (b)(6) years), showing good position of right hip and deterioration of left hip (mp 64%).When the outcome of the worst hip was used in patients with bilateral bony procedures, the outcome was good in 22 patients and poor in 9 patients.When hip was used as the unit of analysis, a good outcome was achieved in 29 out of 39 hips.The rate of good outcome after combined osteotomies was higher (good results in 15 of 18 patients) than that after femoral osteotomy alone (good results in 7 of 13 patients).In the 23 patients with unilateral osteotomies, the contralateral hip deteriorated in 3 patients.2 patients had subluxation with preoperative mp 48% and 51%, respectively, on the contralateral side, and these hips deteriorated postoperatively of the remaining 5 patients with contralateral subluxation (mp 36¿50%) but no contralateral bony surgery, postoperative normalization occurred in 4 patients (mp < 33%) whereas subluxation remained unchanged (mp 38% preoperatively and 40% at follow-up) in 1 patient.Preoperative hip pain had been noted in 10 of the 31 children.1 year postoperatively these patients were painless, but 6 of the other patients had hip pain.At the last follow-up, pain was significantly more frequent in patients with poor radiographic outcome (5 of 9 patients).Postoperative complications occurred in 4 patients.2 children had failure of the femoral fixation and re-dislocation of the osteotomy 1¿3 months postoperatively, which was treated with plate re-fixation in 1 child and plaster cast in the other.Decubitus ulcer of the heel because of pressure from the plaster and pneumonia occurred in 1 patient each.In addition to these early complications, femoral fracture of the operated extremity occurred 1¿5 years postoperatively in 4 patients.The fractures were treated with plate fixation.No obvious reason for failure could be identified in 5 patients (6 hips).The reason was poor primary correction in 3 patients.1 child had repeated femoral fractures of the operated side and also had respiratory problems; therefore, proximal femoral resection was performed after his third fracture.Reoperation has been performed in 5 hips (1 femoral osteotomy, 2 pelvic osteotomies, 1 combined pelvic and femoral osteotomies, and 1 proximal femoral resection).Mp during the entire postoperative period was larger in hips with poor final outcome.The mean postoperative mp progression was less than 1% per year in hips with good outcome and 10% per year in hips with poor final outcome.5 boys patients¿ outcome: failure.4 girls patients¿ outcome: failure.This report is for an unknown synthes pediatric locked compression plate and an ao blade plate.This is report 3 of 6 for (b)(4).Additional reports are captured under (b)(4).
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