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50 patients were included in the study, with a mean age of 75 (range, 55-93) years with 80% women.Exact date of event is unknown; march 22, 2010 is the date the literature article was published.510k: this report is for an unknown synthes philos plates/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.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: olerud, p et al (2010), "quality of life and functional outcome after a 2-part proximal humeral fracture: a prospective cohort study on 50 patients treated with a locking plate." journal of shoulder and elbow surgery volume 19, issue 6, september 2010, pages 814-822 (sweden).The aim of our study was to report the outcome after a displaced 2-part fracture of the proximal humerus in elderly patients treated with a locking plate in a prospective cohort study with a 2-year follow-up.The primary aim was to report the health-related quality of life (hrqol) and our secondary aims were to report the functional outcome according to the constant and dash scores.50 patients were included in the study, with a mean age of 75 (range, 55-93) years with 80% women.They were all treated with open reduction and internal fixation with a synthes philos locking plate between june 2003 and february 2007.Follow-up examinations were performed at 4, 12, and 24 months.The main outcome measures were the constant and dash scores and hrqol according to the euroqol-5d (eq-5d).The mean constant score at 24 months was 61.1 (21.6) and the dash score was 32.4 (25.2).The greater tubercle was undisplaced in 18 patients, displaced 1 mm in 1, 2 mm in 1, 3 mm in 2, 4 mm in 1, and 5 mm in 3 patients.The lesser tubercle was undisplaced in 8 patients, displaced 3 mm in 1, and 5 mm in 1 patient.There was a dislocation of the greater tubercle before the 4-month follow-up in 5 of the 26 patients with an initially undisplaced or minimally displaced fracture of the greater tubercle.In 4 of these patients, the greater tubercle was primarily undisplaced and in 1 patient displaced by 3 mm.A screw penetration of the head on the postoperative radiograph was found in 6 patients , being minor and single in all but 2 cases.One patient had a single screw penetrating the head 6 mm and another patient had 2 screws penetrating 1 and 3 mm, respectively, both being re-operated upon later.Additional screw penetration of the head had occurred at 4 months in 6 patients at risk.The two remaining patients had already had their plate extracted before the 4-month follow-up.All secondary screw penetrations occurred in patients with a changed fracture position.In total, 8 patients were re-operated upon during the 2-year follow-up period.: reoperations due to a suboptimal position of the implant were performed in 3 patients: 1 patient with a primary screw penetration of 6 mm was re-operated with extraction of the penetrating screw after 6 days; 1 patient with a primary screw penetration of 3 mm was reoperated upon with extraction of the plate because of stiffness after 6.1 months, as the screw penetration could not be excluded as a cause of stiffness; and, finally, 1 patient had the plate extracted after 18.3 months due to impingement problems probably caused by too superior a position of the plate: it was 2 mm above the top of the greater tubercle.Reoperations due to secondary displacement were performed in 3 patients: 1 patient with a secondary screw penetration due to minor re-dislocations who was re-operated upon with a screw exchange and screw extraction after 1.6 months.A factor contributing to the failure in this patient may be osteoporosis with a t score of 2.9.One patient had a secondary screw penetration due to minor re-dislocations and was re-operated upon with a screw exchange and screw extraction after 2.8 months.The fracture progressed to a nonunion and the patient was re-operated upon with a hemiarthroplasty after 10.9 months.Finally, 1 patient had a major redislocation of the fracture and was re-operated upon with a hemiarthroplasty after 1.5 months.A possible explanation of the failure may be a suboptimal primary reduction with 43 posterior angulation.Revision surgery due to nonunion was performed in 1 patient who was re-operated upon with re-fixation with a philos 5-hole plate and an autologous bone transplant after 17.4 months with subsequent healing of the fracture.1 patient had a deep infection and underwent repeated wound revisions and lavage, and eventually had a hemiarthroplasty after 2.9 months, which was extracted due to a relapse of infection after 25.4 months.This report is for unknown synthes philos plates.This is report 1 of 3 for (b)(4).
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