MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION ,BONE

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

Patient Problems Hemorrhage/Bleeding (1888); Seroma (2069); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/screws construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2012 and 2017.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: nagy m., pydisetty g., kwaees t., saldanha k.,(2020)outcome of revision surgery for bisphosphonate related subtrochanteric fracture non-union following failed intramedullary nailing, injury xxx (xxxx), pages 1-7(united kingdom).This study aims to present our experience of treating non-union after failed nailing in atypical femur fractures.Between 2012 and 2017, a retrospective study on 10 patients with consecutive long- term bisphosphonate related atypical femur fractures, with failed primary intramedullary nail fixation, resulting in a nonunion and metalwork failure was performed.10 patients (9 female and 1 male) with mean age at surgery was 71.5 y (range 57 to 89 y, sd ¿9.5 y) underwent revision and were included in the study.Initial surgery was performed using a variety of implants.Nine patients had undergone im nailing as first line treatment between 2004 and 2016.Devices used included universal femoral nail, proximal femoral nail an- tirotation (pfna) (synthes), affixus nail (depuy), trochanteric an- tegrade nail (smith & nephew), trigen (smith & nephew).In one case a dcs screw and 95-degree plate was used as initial therapy.Following removal of the failed metalwork and resection of the non-union, a dcs screw and 95-degree dcs plate (12 or 14 or 16 hole) (synthes, leeds, uk), with multiple cortical screws, was inserted.Additional anterior lcp plate (8 or 10 hole) (synthes, leeds, uk), with multiple cortical screws, was inserted.The following complications were reported as follows: one patient was lost to follow-up due to death unrelated to surgery.(case (b)(6)).Reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months.A case of a female patient age at revision was 65.3 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 83.5 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 70.1 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 72.3 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 88.6 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 78.0 (case (b)(6)) underwent revision.(case number 6 figure 1a to 1e) (figure 1c: antero-posterior and lateral radiographs of the right hip demonstrating failed intramedullary nailing with broken nail and fracture non-union).A case of a female patient age at revision was 72.1 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 69.8 (case (b)(6)) underwent revision.(patient lost to follow-up died unrelated to surgery) (reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a male patient age at revision was 56.9 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).A case of a female patient age at revision was 58.5 (case (b)(6)) underwent revision.(reason for revision included failure of initial fixation with breakage of the intramedullary nail or established nonunion at the fracture site with no radiographic or clinical progression of healing for at least of 6 months).Complications included one superficial wound infection (treated with antibiotics) and a sacral pressure sore.Two patients developed a seroma, requiring evacuation and washout in theatre.Four patients needed blood transfusion.One needed hdu admission in the post- operative period.Six patients were allowed to start weight bearing following clinical assessment for fracture union (criteria included being pain-free, no discomfort on straight leg raising and a trial of pain-free weight bearing).However, these patients did not show radiological union, but there was no loss of position of the fracture reduction and no evidence of implant migration or loosening at that stage.There was one periprostethic fracture following successful management of nonunion of subtrochanteric femoral fracture.This patient had been mobilising fully weight bearing after union of the fracture.15 months following revision surgery, the patient had a fall and sustained a periprosthetic fracture at the distal tip of the dcs plate.This required further surgery.In another patient, the dcs plate had undergone fatigue failure 18 months after the index procedure.However, this patient was fully weight bearing and asymptomatic.Ct scan confirmed union of the fracture site.This report is for an unknown synthes proximal femoral nail antirotation (pfna) , dcs, and lcp.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown plate/screws construct.This is report 6 of 8 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 11398869
• MDR Text Key: 247213665
• Report Number: 8030965-2021-01515
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: 02/08/2021
• 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