Product complaint #: (b)(4).510k: this report is for an unk - constructs: pfna/ unknown lot.Part and lot numbers 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 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.Based on the information available, it has been determined that no corrective and 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.
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This report is being filed after the review of the following journal article: cheng q., et al (2020) procedure for femoral intertrochanteric fractures using the ¿three-finger method¿ assisted by proximal femoral nail antirotation, orthopaedic surgery volume 12, number 2, pages 543¿551(china)doi: 10.1111/os.12656.This study aims to investigate the following: (i) to consider a new surgical method of proximal femoral nail antirotation for intertrochanteric fractures assisted by the ¿three-finger method¿ as evaluated by the harris hip score, the incidence of postoperative complications, the incidence of postoperative hip pain, and thefunction of the hip joint; (ii) to explore whether there is a relationship between some postoperative complications andage; and (iii) to discuss the superiority of this surgical method.From january 2010 to january 2017 a total of 123 patients, (56 males,67 females)aged 52¿93 years old with an average age of 72.7 - 12.0 years were selected and followed for the treatment of femoral intertrochanteric fractures with pfna assisted by the ¿three-finger method¿.The longest follow-up time was 8 years, and the shortest follow-up time was 1 year, with an average of 4.2 to 1.8 years.The following complications were reported as follows: among the 123 patients, there were 25 deaths.The cause of death was due to internal medicine diseases.Death (cases) : 1 at 1 year follow-up, 8 at 2 year follow-up; 14 at 4 year follow-up ; 17 at 6 year follow-up; 25 at 8 year follow-up.Bad (cases) : 3 at 1 year follow-up, 2 at 2 year follow-up; 3 at 4 year follow-up ;5 at 6 year follow-up; 6 at 8 year follow-up.During the follow-up of 123 patients, we found that the incidence of hip joint pain was 26.8%: of these, 25.0% were males and 28.4% were females (fig.4).The patients were divided into three groups according to age.Among them, there were 34 patients between 50 and 69 years, eight of which had pain, and the incidence of pain was.There were 51 patients between 70 and 79 years old, 14 of which has pain.There were 38 patients between 80 and 100 years old, nine of which had pain, and the incidence of pain was (fig.5).Three patients in the 50¿69-year age group with difficulty walking and going up and down stairs.There were 40 patients in the 70¿79-year age group.There were 36 patients in the 80¿100-year age group.Three patients had effusion.One of the patients had femoral head necrosis 1 year after surgery.After artificial femoral head replacement, the patient recovered well.This report is for an unknown synthes pfna.This report is for (1) unk - constructs: pfna.This is report 1 of 1 (b)(4).
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