MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Hematoma (1884); Thrombosis/Thrombus (4440)

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.This report is for an unknown constructs: pfna/unknown lot.Part and lot numbers are unknown; udi 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.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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: zhang, w.(2018), a prospective study of hip arthroplasty and internal fixation with antirotation intramedullary nail for functional recovery of elderly patients with intertrochanteric fractures, chinese journal of bone and joint, vol.7 (10), pages 778-782 (china).The aim of this study was to compare the effect of hip replacement (hr) and proximal femoral nail anti-rotation (pfna) internal fixation on functional recovery in elderly patients with intertrochanteric femoral fracture (iff).Between june 2013 to june 2016, a total of 100 elderly patients (60 male and 40 female) with an average age of 71.26 ± 5.27 years were included in the study.According to the treatment method, all patients were divided into the hr group (n = 50; 31 male and 19 female) using hip prosthesis from jrn device and pfna group (n = 50; 29 male and 21 female) using pfna internal fixation system (synthes, usa).The patients were followed up for 12 months by telephone and return visit to evaluate the hip joint function at 6 and 12 months after operation.The following complications were reported as follows: 2 patients had subcutaneous hematoma.1 patient had deep vein thrombosis (dvt).2 patients had bedsores.This report is for an unknown synthes pfna constructs.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 14919305
• MDR Text Key: 295310243
• Report Number: 8030965-2022-04568
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• 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: 06/08/2022
• 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