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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bone Fracture(s) (1870); Sepsis (2067); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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.Product was not returned.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: thomas m.Large et.Al (2008), locked plating of supracondylar periprosthetic femur fractures, the journal of arthroplasty vol.23, no.6, s1, pages 115-120 (usa).The aim of this study was to mobilize this difficult patient population early, avoiding the sequelae of immobilization and minimizing reoperations and complications.Between 1995 to 2005, a total of 50 patients with a mean age of 74.8 were included in the study.These patients were diagnosed with supracondylar femur fractures above a total knee arthroplasty (tka).There were 2 groups.Group i had 29 patients were 27 patients were treated with synthes liss and 2 patients were treated with lateral 4.5-mm locking condylar plate.In group ii, there were 21 patients in which there were only 15 patients available for follow-up.18 patients treated with a competitor¿s device.3 were treated with short depuy ace universal nails and 4 long synthes distal femoral nails.The mean duration of follow-up of group i was 1.7 years and 3.4 years in group ii.The following complications reported as follows: group 1: deep sepsis which was treated with above the knee amputation.Fracture above plate 5 months out, treated with antegrade nailing proximal liss screw revision.Liss plate removal for hardware irritation.5 patients had malunion.Group 2: proximal tibia fracture of the imn which was healed with nonoperative treatment.Poor intraoperative distal interlock fixation which was augmented with the intraoperative medial plate.Tibia fracture postoperatively which was healed with nonoperative treatment.Inadequate intraoperative fixation with varus/valgus instability had an intraoperative revision to oncology salvage tka.Prominent nail (imn) which was removed with tka revision.5 patients had malunion.4.5-mm dcs nonunion was revised to liss; subsequent tka revision to constrained tka for aseptic loosening.Imn nonunion was revised broken imn interlock screws, autogenous bone grafting, medial plating.Imn nonunion revised to oncology salvage tka.This report is for an unknown synthes 4.5 mm locking condylar plate.This is report 1 of 8 for (b)(4).

• Brand Name: UNK - PLATES
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9175427
• MDR Text Key: 167597389
• Report Number: 2939274-2019-61384
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 09/23/2019
• 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