Pma/510k: this report is for an unk constructs: plate/screws/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.
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This report is being filed after the review of the following journal article: hart g., et al (2017) open reduction vs distal femoral replacement arthroplasty for comminuted distal femur fractures in the patients 70 years and older, the journal of arthroplasty volume 32, pages 202-206 (usa) http://dx.Doi.Org/10.1016/j.Arth.2016.06.006.This retrospective study aims to review our experience treating intra articular distal femur fractures in an elderly cohort of patients.From 2007 to 2012,a total of 229 patients underwent treatment for 230 distal femur fractures.38 fractures included in the study.Of these patients, 10 underwent dfr and 28 orif.28 patients (26 females, 2 males) undergoing orif mean patient age was 82.0 years (range, 70.2-96.7), were treated with either the smith and nephew peri-loc locking distal femur plate (smith and nephew, memphis, tn) or the synthes lcp locking distal femur plate (synthes,west chester, pa).10 patients who underwent dfr who were all women with mean age of 81.8 years (range, 70.9-91.7; p ¼.95) were treated with the biomet orthopaedic salvage system (biomet,warsaw, in) or the zimmer segmental system distal femur (zimmer, warsaw, in) or the stryker global modular replacement system (stryker, mahwah, nj).One-year follow-up was available for 29 of the initial 38 patients , 7 of 10 of the dfr cohort, and 22 of 28 of the orif cohort.The following complications were reported as follows: one patient died before treatment.One of the dfr patients died before leaving the hospital.1 superficial infection and 1 deep infection occurred.Five of the patients who underwent orif developed a nonunion.Three of these patients went on to undergo revision surgery, 1 requiring an irrigation, debridement, and revision orif for an infected nonunion, while the other 2 underwent revision orif with bone grafting.In the orif cohort,(6/22) of patients were able to ambulate independently at 1 year, while (3/22) required a cane, (8/22) required walker, and (5/22) were wheelchair dependent.This report is for an unknown synthes lcp locking distal femur plate.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk, constructs: plate/screws.This is report 1 of 1 for (b)(4).
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