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

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unknown plates: distal femur/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: virkus w., et al (2022) results of low distal femur periprosthetic fractures, journal of orthopaedic trauma xxxx, pages 1 -29 (usa).This retrospective study aims to compare outcomes of very distal periprosthetic distal femur fractures (pdffs), defined by a fracture at or distal to the anterior flange of the total knee arthroplasty (tka) prosthesis, treated by retrograde intramedullary nail (rimn) versus open reduction and internal fixation (orif) with locking screws.Between march 2013 through december 2016, patients 50 years or older who underwent fracture fixation were reviewed.Of 56 eligible patients, 48 met inclusion/exclusion criteria.Patients were treated by rimn or orif based on treatment determined by surgeon preference.All 36 retrograde intramedullary nail (rimn) cases (33 females and 3 males) age 73.3 (9.9) years , utilized modern nails with distal multiplanar fixation (stryker scn nail, allendale, nj).12 open reduction and internal fixation (orif) cases (11 females and 1 males) age 75.9 (11.4) years utilized modern distal femur locking plate constructs (stryker axsos distal femur plate, allendale, nj- (n=8), synthes locking condylar plate, paoli, pa- (n=2), synthes variable angle locking condylar plate, paoli, pa- (n=1), synthes less invasive stabilization system (liss), paoli, pa-(n= 1)).One simple fracture was treated with lag screws and a neutralization plate.All other fractures were treated with a bridge plate construct with locking metaphyseal screws and hybrid (mix of locking and non-locking shaft screws).Mean follow up was 27 months (range: 12-55 months).The following complications were reported as follows: eighteen patients were deceased prior to data collection.1 reoperation (one distal femoral replacement for infection (deep infection).1 malunion in sagittal plane >10 degrees from pdfa/sag.1 postop change in fracture alignment.4 transfusion.1 early fixation failure ,converted to rimn.The patient failed to adhere to weight-bearing restrictions and had early (two week) implant failure.Evidenced by bending of the plate and 15 degrees varus malalignment.This was revised with an imn and healed uneventfully.A second patient in the orif group was diagnosed with nonunion after the plate broke four months postoperatively and went on to heal after exchange nailing and bone grafting.This report is for an unknown synthes locking condylar plate, unknown synthes variable angle locking condylar plate,unknown synthes less invasive stabilization system (liss).This is report 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14593966
• MDR Text Key: 293281439
• Report Number: 2939274-2022-02051
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 06/03/2022
• 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