This report is for an unknown constructs: dhs/dcs/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: gashi, y.N., elhadi, a.S.And elbushra, i.M.(2018), outcome of primary cemented bipolar hemiarthroplasty compared with dynamic hip screw in elderly patients with unstable intertrochanteric fracture, malaysian orthopaedic journal, vol.12 (no.1), pages 36-41 (sudan).The aim of this prospective cohort hospital-based study is to compare the outcome of primary cemented bipolar (pcb) hemiarthroplasty with dhs in the management of comminuted intertrochanteric hip fractures in elderly patients.Between 2014 to 2016, a total of 98 patients were included in the study.Of these, 38 patients (20 male and 18 female), with a mean age of 79.3 years, were treated with dynamic hip screw (dhs).All patients were seen at two weeks, six weeks, and 12 weeks postoperatively, and at the final follow-up.Mean follow-up was 11.8±2.7 months at dhs group.All patients were evaluated using harris hip score at three months and at the final follow-up to assess functional outcomes.The following complications were reported as follows: 6 patients died, 5 patients were lost to follow-up.47.4 percent of the dhs group needs blood transfusion.7 patients had a complication with infection, of whom five cases were superficial, managed with debridement and antibiotics, and two cases were deep necessitating removal of implants and revision in one case, with external fixation and removal with debridement in the other.5 patients had general complications.2 patients had deep venous thrombosis.3 patients had bedsore.1 patient had delayed union.1 patient had non-union revised with hemiarthroplasty.3 cases had varus malunion and 2 cases ended with medialization.All patients in the dhs group started full weight bearing at 6 to 12 weeks postoperatively.The mean harris hip score at 12 weeks postoperatively was 52.97±16.2, and at final follow-up was 74.11±13.8.4 patients had cut-out and penetration into acetabulum which was revised later with hemiarthroplasty.This report is for an unknown synthes dynamic hip system (dhs) this is report 1 of 2 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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