MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL FEMUR; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: lcp distal femur/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 conclusion could be drawn at the time of filing this report.The product was not returned.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.

Event Description

Device report from synthes reports an event in korea, south as follows: this report is being filed after the review of the following journal article: jang h.J., rhee s.J., jun s.B., choi y.Y., (2021) scattering and clustering the proximal screw construct in unilateral locking plate osteosynthesis of distal femoral fractures, archives of orthopedic and trauma surgery volume xxxx, pages 1-11 (korea, south).This study aims to report the in vivo results of different fixation constructs in the unilateral lcp in as controlled a manner as possible by minimizing the differences in the demographic characteristics.From 2014 to 2019, 114 distal femoral fractures were operated on by the two surgeons in the authors¿ trauma center and enrolled in this retrospective study.The inclusion criterion for this study was a metaphyseal fracture distal to one-third of the femur (ao type 33-a and c) operated using the unilateral distal femur locking compression plate (dflcp, depuy-synthes, oberdorf, switzerland) at least a 12-month follow-up period.Sixty-five patients with 70 fractures were included in this study.There were 35 fractures in 33 patients (22 males, 11 females) with a mean age of 51.0 (range, 18¿75) years in group 1, and 35 fractures in 32 patients (22 males, 10 females) with a mean age of 51.9 (range, 16¿85) years in group 2.The patients were allocated to two groups.Fractures that were operated on using the scattered proximal screw fixation construct with a short bridge span (working length less than 4 in 9 and 11hole plates, and less than 6 in 13-hole plate) were assigned to group 1, and fractures which were operated on using the clustered proximal screw fixation construct with a long bridge span (working length longer than 4 in 9- and 11-hole plates, and longer than 6 in 13-hole plate) were assigned to group 2.Follow-up radiography was performed immediately after the operation, and 1 week, 2 weeks, 1 month, 2 months, 3 months postoperatively.A follow-up visit was repeated every three months after three postoperative months.The mean period of follow-up was 23.6 months for group 1 and 21.3 months for group 2.The following complications were reported: group 1: 2 nonunion, cases an auto-iliac bone grafting was performed as a revision for one nonunion.Plate rem oval was performed in 14 out of 35.Mean time point of plate removal was 20.9 ± 5.6 months after the definite fixation.11 asymmetric union: anterolateral defect (n=4), anterior defect , (n=3), anteromedial defect (n=2), anteroventral defect (n=1), and posteromedial defect (n=1).Group 2: 3 nonunion, one additional screw insertion, one plate change, and one conversion to retrograde intramedullary nail were performed as a revision for three nonunion.Plate removal was performed in 18 out of 35 in group 2.Mean time point of plate removal as 19.7 ± 4.9 months.Mean time required to achieve radiological union was longer in group 2 than in group 1.17 asymmetric union in group 2:anterolateral defect (n=9), anterior defect , (n=1), anteromedial defect (n=4), anteroventral defect (n=2),lateral defect (n=1).Locking screw breakage was observed in two cases group 1.Locking screw breakage was observed in four cases in group 2.Plate breakage in two cases in group 2.This report is for an unknown synthes distal femur locking compression plate (dflcp).This report is for (1) unk - plates: lcp distal femur.This report is 1 of 7 for (b)(4).

• Brand Name: UNK - PLATES: LCP DISTAL FEMUR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12529721
• MDR Text Key: 275419622
• Report Number: 8030965-2021-08040
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention