MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PFNA-II; ROD, FIXATION, INTRAMEDULLARY

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: yoo, h., cho, y., and hwang, s.(2019), outcomes of combined neck and trochanter fractures of the femur treated with cephalomedullary nail in elderly, hip pelvis, vol.31(4), pages 200-205, (south korea).The purpose of the current study was to report the outcomes of combined neck and trochanter fractures of the femur treated with cmn in elderly patients.Between january 2010 and december 2014, a total of 33 patients (29 females and 4 males) wit an average age of 77 years (61-90 years) underwent internal fixation with cephalomedullary nail (cmn) using proximal femoral nail anti-rotation ii (pfna ii; synthes, oberdorf, switzerland).The following complications were reported as follows: 2 patients died fewer than three months after injury.(b)(6) year-old female patient had implant fracture and was revised with bipolar hemiarthroplasty.(b)(6) year-old female patient had a cut through and was revised with bipolar hemiarthroplasty.(b)(6) year-old female patient had a cut-out and was revised with bipolar hemiarthroplasty.(b)(6) year-old female patient a cut through and was revised with bipolar hemiarthroplasty.(b)(6) year-old male patient had implant loosening with persistent nonunion at the end of follow-up.He had refused revision surgery until 49 months after the index surgery because he had a little pain, low demand in daily life and many medical problems.This is report 5 of 5 for (b)(4).This is for a proximal femoral nail anti-rotation ii (pfna) construct.

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9871424
• MDR Text Key: 194133711
• Report Number: 8030965-2020-02192
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• 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
• Patient Age: 82 YR