MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: TRAUMACEM; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Unspecified Infection (1930); Non-union Bone Fracture (2369); Malunion of Bone (4529); Physical Asymmetry (4573); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown biomaterial - cement: traumacem/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: fernandez, m.Et al (2023), augmented versus non-augmented trochanteric fixation nail-advanced (tfna) nails for treating trochanteric fractures in patients over sixty-five years of age, international orthopaedics xx.Xx., pages 1-10 (france).The aim of the study was to compare mechanical failure rates between augmented and non-augmented tfna nails in the treatment of trochanteric fractures in patients aged > 65 years.Between (b)(6) 2021, a total of 232 patients who underwent treatment with a short tfna nail with traumacem v + cement was included in the study.During the study, 4 patients were subsequently excluded for various reasons, 18 patients lost to follow-up, and 29 patients died before the 6 months of follow up.Thus, the study cohort comprised of 181 patients (40 male and 141 female) with a mean age of 82.53 years were included for the analyses.These patients were divided into two groups: the augmented group (with an augmented tfna nail) with 103 patients (22 male and 81 female) with a mean age of 82.52 years, and the non-augmented group (that had a non-augmented tfna nail) with 78 patients (18 male and 60 female) with a mean age of 82.54 years.All patients were followed-up to 6 months post-surgery.The following complications were reported as follows: 1 patient had immediate postoperative stroke resulting in significant spasticity.1 patient had an inadequate cement usage.1 patient with high intra-articular cement leakage risk during surgery.1 patient that had equipment misplacement that required surgical revision on the following day 29 patients died before 6 months follow-up.Augmented group.1 patient had cut-out at 3 months post-operative and underwent non-anatomical reduction1 patient with implant failure caused by a femoral neck fracture after a low-energy event at two months postoperative required revision surgery for intermediate hip arthroplasty.2 patients with secondary displacement.2 patients with surgical site infection.1 patient with intracapsular hematoma.1 patient with vicious attitude.1 patient with lower limb length discrepancy of > 1 cm at 6 months postoperative and underwent non-anatomical reduction.12 patients with 3-month mortality.15 patients with 6-month mortality.Non-augmented group.-9 patients had cut-out and underwent revision for total hip arthroplasty using the posterior method.2 patients with secondary displacement.1 patient with pseudoarthrosis.3 patients with surgical site infection.13 patients with 3-month mortality.14 patients with 6-month mortality.This report is for an unknown synthes traumacem v + cement.A copy of the literature article is being submitted with this medwatch.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: TRAUMACEM
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18504526
• MDR Text Key: 332880427
• Report Number: 8030965-2024-00808
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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
• Date Manufacturer Received: 01/02/2024
• 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