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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article ¿should the tip-apex distance (tad) rule be modified for the proximal femoral nail antirotation (pfna)? a retrospective study.¿ nikoloski, a.N., osbrough, a.L., and yates, p.J.(2013).Journal of orthopaedic surgery and research, 8, 35.The authors retrospectively identified 187 patients who had 188 fractures treated with the synthes proximal femoral nail antirotation (pfna) (synthes (b)(4)) between august 2006 and october 2007.One hundred eighty-eight pfnas were implanted during the study period, with 178 cases included in this study (ten patients were excluded because they either had the nail implanted as fracture prophylaxis for a tumour or as an intracapsular or diaphyseal region fracture).Demographics included 128 females, 50 males; ages ranged from 36 to 99 years old with a mean of 81.5 years old.Ninety-seven patients could be followed up clinically.Fractures were classified according to arbeitsgemeinschaft für osteosynthesefragen/association for the study of internal fixation (ao/asif).Postoperative radiographs obtained in the routine treatment of patients were studied for review looking primarily for cut-out.There were 18 surgical implant-related failures identified in the study.The single most common mode of failure was cut-out in six cases.Three cut-outs (two medial perforation and one varus collapse) occurred with tip-apex distance (tad) less than 20 mm.There were no cut-outs in cases where the tad was from 20¿30 mm.There were three implant-related failures (nail fracture, missed nail, and loose locking screw).Other complications in the order of frequency were three intraoperative femur, two periprosthetic fractures (distal to the tip of the nail), two cases of delayed union, and two cases of nonunion.The intraoperative femur fractures all occurred when using long nails.Both non-unions occurred in subtrochanteric fractures.The authors concluded that the pfna is a suitable fixation device for the treatment of unstable proximal femoral fractures.There were still a relatively large number of cut-outs, and the tip-apex distance in the failures showed a bimodal distribution, not like previously demonstrated with dynamic hip screw.We propose that the helical blade behaves differently to a screw, and placement too close to the subchondral bone may lead to penetration through the head.This is report 1 of 1 (b)(4).This report is for unknown proximal femoral nail antirotation nails, helical blades, and screws.A copy of the journal article is being submitted with this medwatch.This report is for 3 unknown devices.

Manufacturer Narrative

Additional narrative: this device is for an unknown proximal femoral nail antirotation helical blade/ unknown lot.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: 3726150
• MDR Text Key: 4312043
• Report Number: 2520274-2014-10536
• 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: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention