MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Shin, young-soo and et al.(2017) "prospective randomized study comparing two cephalomedullary nails for elderly intertrochanteric fractures: zimmer natural nail versus proximal femoral nail antirotation ii.This report is for unknown - proximal femoral nail antirotation blade.Part and lot numbers are unknown.Without the specific part and lot number; the udi number is not available.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filed after the subsequent review of the following literature article shin, young-soo and et al.(2017) "prospective randomized study comparing two cephalomedullary nails for elderly intertrochanteric fractures: zimmer natural nail versus proximal femoral nail antirotation ii".Injury, int.J.Care injured, volume 48 (2017) 1550-1557.(south korea) this prospective study was comprised of patients with intertrochanteric hip fractures who underwent cephalomedullary nailing between january 2011 and august 2014.A total of 380 patients participated in the study and were divided into two groups; group i was treated with a zimmer natural nail and group ii was treated with a synthes proximal femoral nail antirotation ii (pfna).At six (6) weeks six (6) patients (five (5) from the zimmer group i and one (1) pfna group ii) were lost to follow up because they couldn't be contacted or died.It is unknown which group the death occurred in.At six (6) months an additional 21 patients were lost to follow up between both groups and another six (6) patients died within the follow up period.It is unknown which group the deaths occurred in.Each patient was followed up postoperatively the day of surgery, 6 weeks, 6 months and 1 year through clinical and radiological exams.Complications: 1 unknown death before 6 week post-operative exam 6 unknown deaths before 6 month post-operative exam it is unknown which group the deaths were attributed to but they will be captured for assessment.5 cases of avascular necrosis of the femoral head 6 cases of revision surgery to a arthroplasty due to unknown causes 1 case of patient pain which resulted in revision surgery and removal of the pfna blade 3 cases of implant failure (cut-out) this report is for unknown - proximal femoral nail antirotation blade.This report is for 3 cases of implant failure (cut-out) this is report 2 of 2 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester 19380 ; 6107195000
• MDR Report Key: 7342443
• MDR Text Key: 102514810
• Report Number: 8030965-2018-52108
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention