MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CEMENT: TRAUMACEM; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number UNK - BIOMATERIAL - CEMENT: TR

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

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unknown biomaterial - cement: traumacem/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.(b)(4).Investigation summary 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, 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kammerlander, c.Et al (2018), cement augmentation of the proximal femoral nail antirotation (pfna) ¿ a multicentre randomized controlled trial, injury, vol.49 (8), pages 1436-1444 (germany).The aim of this prospective multicentre, randomized, patient-blinded trial is to investigate the clinical effects of the additional use of bone cement with the pfna in mobile elderly patients with closed unstable trochanteric fractures on functional outcome as indicated by the postoperative recovery of walking speed.Between march 2012 to july 2015, a total of 223 patients (37 male and 186 female) were included in the study.The pfna augmentation group consists of 105 patients (18 male and 87 female) with a mean age of 86.1 (4.6) years.While the pfna group consists of 118 patients (19 male and 99 female) with a mean age of 85.6 (4.9) years.Surgery was performed using proximal femoral nail antirotation with a helical blade (pfna; depuy synthes, oberdorf, switzerland) and a polymethylmethacrylate (pmma) traumecem v+ cement (depuy synthes, oberdorf, switzerland).85/105 patients were allocated to the pfna augmentation group received their intended treatment and 20 patients crossed over to the pfna group.In the pfna group, 3 of 118 patients did not receive their intended treatment: of those, 2 patients crossed over to the pfna augmented group.For the primary outcome analysis, 125 patients were available.Outcomes were evaluated at baseline (before surgery), during surgery, 3 to 14 days after surgery, 3 months, 6 months, and 12 months after surgery.The following complications were reported as follows: pfna group: 11 patients died.6 patients underwent reoperations in the pfna group (1 patient had implant breakage, 1 a cut-out of blade, 1 loosening of the blade and 3 patients had irritations of the tractus iliotibialis due to lateral blade migration).8 patients had intraoperative complications (1 hypersensitivity or allergy, 1 patient had event leading to change of surgical procedure, 1 patient had poor intraoperative fracture reduction, 5 patients had other intraoperative adverse events).1 patient had a malunion/loss of reduction.4 patients had a refracture secondary fracture.3 patients had a peri-implant fracture.1 patient had neurological symptoms (dys-paraesthesia) 1 patient had a superficial wound infection.3 patients had a hematoma (requiring revision).1 patient had thromboembolic complications.1 had sepsis.6 patients had delirium.8 patients had pneumonia.2 patients had renal insufficiency.1 patient had bleeding (gastrointestinal cerebral).In 5 patients, a cardiac (myocardial infarction new arrhythmia) was noted.6 patients had a stroke.41 patients had other postoperative events.Pfna augmentation group: 9 patients died.1 patient had cement leakage.2 patients had malunion/loss of reduction.3 patients had a refracture secondary fracture.1 patient had a peri-implant fracture.3 patients had a superficial wound infection.1 patient had a hematoma.4 patients had thromboembolic complications.2 patients had delirium.2 patients had pneumonia.2 patients had renal insufficiency.1 patient had bleeding.In 5 patients, a cardiac (myocardial infarction new arrhythmia) was noted.2 patients had a stroke.30 patients had other postoperative events.This report is for an unknown synthes pfna construct, unknown synthes pfna blade, and unknown synthes traumacem cement.This report is for one (1) biomolateria - cement: traumacem.This report is 5 of 5 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: TRAUMACEM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9578785
• MDR Text Key: 188376095
• Report Number: 8030965-2020-00274
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BIOMATERIAL - CEMENT: TR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• 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