MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: LCP DISTAL FEMUR; PLATE, FIXATION ,BONE

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2005 to 2015.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.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.

Event Description

This report is being filed after the review of the following journal article: tibbo, m.E.Et al.(2021), distal femoral replacement versus orif for severely comminuted distal femur fractures, european journal of orthopaedic surgery & traumatology, vol.Xx, pages 1-6 (usa) the aims of this study were to compare implant survivorship, perioperative factors, and clinical outcomes of distal femoral replacement (dfr) vs.Orif for comminuted distal femur fractures.From 2005 to 2015, 20 patients underwent orif using a locking compression condylar plate (depuy-synthes) for 14 patients and a less invasive stabilization system (liss®, depuy-synthes) for 2 patients.There were 12 females and 8 males with a mean age of 76 years (range, 56¿90 years).The mean follow-up was 29 months (range, 4¿85 months).The following complications were reported as follows: 1 patient died with less than 1 year of follow-up.Survivorship free from any revision: 3 patients had nonunion which were treated with revision orif.Two patients originally treated with a laterally based locked plate were revised to another laterally based-plate with iliac crest bone graft (icbg) and one with autogenous grafting obtained using the reamer-irrigatoraspirator (ria).2 patients with a symptomatic malunion were converted to dfr.Survivorship free from any reoperation: 1 patient had knee stiffness which was treated with manipulation under anesthesia.1 patient had an infection which was treated with an irrigation and debridement.2 patients had delayed union were treated with bone stimulators only, as both were considered too medically ill to undergo revision surgery.Both patients with a delayed union died prior during the follow-up period, one within 5 months of fracture fixation, and one at the 2 years after index surgery.1 patient had severe soft tissue loss associated with the initial injury which was treated with split-thickness skin grafting two days following orif.1 patient had varus malunion which was managed conservatively as medical illness prohibited revision surgery.This report is for an unknown synthes locking compression condylar plate and less invasive stabilization system.This report is for (1) unknown plate/screw construct.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LCP DISTAL FEMUR
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12528570
• MDR Text Key: 275052795
• Report Number: 2939274-2021-05755
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Date Manufacturer Received: 10/06/2021
• 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