43 patients with subtrochanteric fractures in the proximal femur treated with an unknown ao dynamic condylar screw (dcs) were included in the study.There were 28 females and 15 males with the mean age of 76.5 years (range, 41-97).510k: this report is for an unknown ao dynamic hip system (dhs)/dynamic condylar system (dcs) 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.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: warwick dj.Et al (1995), the dynamic condylar screw in the management of subtrochanteric fractures of the femur, injury: international journal of the care of the injured, volume 26, number 4, page 241-244, (united kingdom).This study reports the use of the ao dynamic condylar screw (dcs) in the treatment of subtrochanteric fractures.Between 1988-1993, 43 patients with subtrochanteric fractures in the proximal femur treated with an unknown ao dynamic condylar screw (dcs) were included in the study.There were 28 females and 15 males with the mean age of 76.5 years (range, 41-97).1 fracture was treated due to a non-union of a subtrochanteric fracture treated by an unknown ao dynamic hip screw (dhs) while 1 fracture was distal to a dhs used for an intertrochanteric fracture.Intraoperatively, the standard ao techniques were used.2 patients with metastases had cement augmentation, 6 patients had iliac crest bone graft on the medial cortex, 9 patients had supplementary lag screw fixation and 1 patient had medial compression plate.Postoperative mobilization used was partial weight bearing for patients with type a fractures while non-weight-bearing for type b and c fractures until callus appeared.Complications were reported as follows: 4 patients had wound infection.2 patients had deep vein thrombosis that was proven venographically.2 patients had pressure sores.1 patient had a chest infection.1 patient had the femur fractured distal to the plate at 6 weeks while partial weight bearing and was revised with a longer plate and bone graft.1 patient with type a fracture, in which primary bone graft had not been used, united only after a secondary bone graft that was performed at 20 weeks.This report is for an unknown ao dynamic hip system (dhs)/dynamic condylar system (dcs) construct.This is report 2 of 4 for (b)(4).
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