MAUDE Adverse Event Report:; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿incidence and radiologic outcome of intraoperative lateral wall fractures in ota 31a1 and a2 fractures treated with cephalomedullary nailing¿ (2012, november).Boopalan, p.R.J.V.C., et al.Journal of orthopaedic trauma (26:11, 638-642).This retrospective study included all patients with pertrochanteric fractures treated with a specific cephalomedullary nail (proximal femoral nail antirotation (pfna); synthes, paoli) seen at a follow-up clinic between january 2005 and january 2009 at a university hospital.One hundred sixty-five of 231 patients, who had completed a follow-up of more than a year after surgery or by the time of failure, were included for the analysis.Surgery was considered a failure if reoperation was necessary due to penetration of the implant from the proximal femur into the hip joint or external to the femur, loosening or fracture of the implant itself, or additional femoral fractures around the implant.The primary end point of the study was either fracture union or failure of treatment.There were four failures.An 82 year old female, a 72 year old female, a 78 year old male, and an 84 year old female, all experienced varus collapse with blade perforation (cut out) which were all converted to total hip arthroplasties.It was concluded that the incidence of intraoperative lateral wall fracture in ota 31a1 and a2 pertrochanteric fractures after cephalomedullary nailing is similar to sliding hip screws.The presence of lateral wall fracture did not adversely affect healing of pertrochanteric fractures.This report is for an unknown pfna which includes unknown nails, helical blades, and screws.

Manufacturer Narrative

This report is for unknown pfna nails/unknown lots.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.

• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3726168
• MDR Text Key: 4312577
• Report Number: 2520274-2014-10583
• Device Sequence Number: 1
• Product Code: JDO
• 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: Other
• Type of Report: Initial
• Report Date: 03/27/2014

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?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/03/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention