This report is for an unknown dynamic hip screw (dhs)/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.(b)(4).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).
|
This report is being filed after the review of the following journal article mellick j.Chehade et, al (2015), influence of fracture stability on early patient mortality and reoperation after pertrochanteric and intertrochanteric hip fractures, journal of orthopaedic trauma vol.29(12), pages 538 - 543 (australia) doi: 10.1097/bot.0000000000000359.The aim of this article is to investigate the influence of fracture stability on early complications requiring reoperation of extramedullary and intramedullary devices.Between january 1, 2003 to june 1, 2007, a total of 743 surgically treated 259 stable pertrochanteric fractures, 107 unstable pertrochanteric, and 14 unstable intertrochanteric fractures in 728 patients (527 males and 216 females) with a mean age of 84 years (range, 36-106 years) were included in the study.These patients were treated dynamic hip screw (dhs) and 2 competitors¿ device.The mean follow-up for surviving patients was 4 years (range, 2-6 years).The following complications were reported as follows: 388 patients with 397 hip fracture died.2 postoperative periprosthetic fractures, both in hips with pertrochanteric hip fractures.1 patient had reoperation due fracture nonunion under unstable intertrochanteric fracture.1 patient had reoperation due arthritis under unstable intertrochanteric fracture.1 patient had reoperation due to device fracture under unstable pertrochanteric fracture.1 patient had reoperation due to screw cutout/loosening under stable pertrochanteric fracture.2 patient had reoperation due to screw cutout/loosening under unstable pertrochanteric fracture.This report is for an unknown dynamic hip screw (dhs).It captures 2 postoperative periprosthetic fractures, both in hips with pertrochanteric hip fractures, reoperation due fracture nonunion under unstable intertrochanteric fracture and reoperation due arthritis under unstable intertrochanteric fracture.This is report 1 of 4 for (b)(4).
|