MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Failure to Osseointegrate (1863)

Patient Problems Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article, tang, p., hu, f., shen, j., zhang, l.And zhang, l.(2012).Proximal femoral antirotation versus hemiarthroplasty: a study for the treatment of intertrochanteric fractures.Injury, int.J.Care injured, 43, 876-881.The authors conducted a retrospective controlled study of 303 patients, mean age 81.7 years, with intertrochanteric fractures during the years 2003 to 2009.One hundred forty seven patients (77 men and 70 women) were treated with proximal femoral nail antirotation (pfna) developed by arbeitsgemeinschaft fur osteosynthesefragen / association for the study of internal fixation and 156 patients (85 men and 71 women) underwent hemiarthroplasty.The average follow-up period was 39.9 months.Two hundred ninety patients were followed up successfully with an eventual 202 patients who were eligible for functional outcome comparison between the two groups (pfna: 106 patients; hemiarthroplasty: 96 patients).Complications in the pfna group involved four cut out / migration, four malrotation, two shortening more than five centimeters, one serious local pain and one unsatisfactory primary osteosynthesis treated with an emergent reosteosynthesis.Six patients needed unspecified secondary surgery.Ten patients rated their harris grade functional outcome as: bad.A copy of the literature article is attached to this medwatch.This report is 1 of 3 for (b)(4).This report is for an unknown pfna construct and refers to four malrotation, two shortening more than five centimeters, one serious local pain and one unsatisfactory primary osteosynthesis treated with an emergent reosteosynthesis.Six patients needed unspecified secondary surgery.Ten patients rated their harris grade functional outcome as: bad.

Manufacturer Narrative

(b)(4): tang, p., hu, f., shen, j., zhang, l.And zhang, l.(2012).Proximal femoral antirotation versus hemiarthroplasty: a study for the treatment of intertrochanteric fractures.Injury, int.J.Care injured, 43, 876-881.This report is for an unknown pfna construct/unknown quantity/unknown lot.Screw, fixation, bone; hwc.Pertains to malrotation, shortening and functional outcome rating as: bad.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4303712
• MDR Text Key: 5057156
• Report Number: 2520274-2014-15163
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 11/19/2014

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: 11/19/2014
• Initial Date FDA Received: 12/08/2014
• 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