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 Ossification (1428); Unspecified Infection (1930)

Event Type  Injury  

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: zuo sl (2019), risk assessment of hemiarthroplasty and internal fixation of proximal femoral nail antirotation for treating hip fractures in older adults, zhongguo zuzhi gongcheng yanjiu.2019; 23 (28): 4440-4445; doi:10.3969/j.Issn.2095-4344.1329 (china).The objective of the study is to compare the preoperative prediction and actual mortality in senile hip fracture treated with different implants based on portsmouth-physiological and operative severity score for the enumeration of mortality and morbidity, so as to explore the clinical application value of the scoring system.Between january 2016 to january 2017, 166 patients above 70 years of age with femoral neck fracture or intertrochanteric fracture who underwent surgery were included in the study.There were 95 males and 71 females.The patients were divided into 2 groups according to the implant, in which 85 patients with femoral neck fracture in hemiarthroplasty group received hemiarthroplasty (bipolar artificial femoral head replacement) using a competitor¿s device, and 81 patients with intertrochanteric fracture in femoral nail group received closed reduction and internal fixation using an unknown synthes proximal femoral nail antirotation.Complications were reported as follows: 2 patients had infection.3 patients had heterotopic ossification and bone resorption.8 patients died.This report is for the unknown synthes proximal femoral nail antirotation.This is report 1 of 1 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

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.Additional narrative: 510k: this report is for an unknown constructs: pfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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.

• 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 ; SZ ; 6103142063
• MDR Report Key: 15313171
• MDR Text Key: 298825760
• Report Number: 8030965-2022-06090
• 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

• 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
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/29/2022
• 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