MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VA-LCP; PLATE,FIXATION,BONE

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

Patient Problems Ossification (1428); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp 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.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: loucas m, et al.(2021), interprosthetic femoral fractures surgical treatment in geriatric patients, geriatric orthopaedic surgery & rehabilitation, volume 12, pages 1-7, (switzerland).This study aimed to present our experience in managing of interprosthetic femoral fractures following ipsilateral hip and knee joint replacement, with particular emphasis on the individual treatment and outcome of the patients.Between 2011 and 2019, 12 patients with interprosthetic femur fracture with well-fixed total hip and knee components were included in the study.There were 10 females and 2 males with a mean age of 86.5 years (range, 79-89 years) and a mean bmi of 27.1 kg/m2 (range, 25.8-27.9 kg/m2).All patients were treated with open reduction and internal fixation using a locked-plated construct and a lateral approach.There were 2 different plate designs used: unknown synthes less invasive stabilization system (liss) plate in 10 patients and unknown synthes variable angle¿locking compression plate (va-lcp) in 3 patients.Postoperatively, weight-bearing restrictions were defined individually depending on bone quality, expected stability of the osteosynthesis as well as the patients¿ cognitive and physical abilities and their comorbidities: 4 of the 12 patients were restricted to no weight-bearing (wheelchair) for 6 to 8 weeks, while 7 were allowed partial and only 1 immediate full weightbearing.There were 2 patients who were physically unable to perform partial weight-bearing and were therefore restricted to no weightbearing.Clinical examination was performed at regular and consistent intervals for clinical and radiographic signs of a union at 2, 6, 12, and 24 weeks postoperatively and then yearly after that or until fracture union and full-weight-bearing status were met.Complications were reported as follows: 1 patient had symptomatic hardware complications due to iliotibial band contact with the plate, which was painful, particularly during knee flexion/ extension.1 patient had persistent pain in the affected leg.2 patients required a wheelchair for mobilization.3 patients used a wheeled walker.2 patients had severe heterotopic ossification (brooker 3/ grade c).2 patients died 3 months postoperatively unrelated to implant surgery.3 patients died 1 year postoperatively and unrelated to implant surgery.This report is for the unknown synthes variable angle¿locking compression plate (va-lcp).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VA-LCP
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12529090
• MDR Text Key: 273322256
• Report Number: 8030965-2021-08042
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 08/27/2021
• 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