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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown femoral nail antirotation (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: kim s., park h., lee d., lee j.,(2018) does short-term weekly teriparatide improve healing in unstable intertrochanteric fractures?, journal of orthopaedic surgery, volume 26(3), pages 1¿7 (south korea).This study aims to evaluate whether the administration of short-term pth could improve early postoperative outcomes including clinical scores, radiographic fracture healing, and complication rates.Between 2014 and 2016, a total of 104 underwent reduction and internal fixation with a short femoral nail for unstable intertrochanteric fractures.Out of these patients, the final study groups were 96 patients (96 hips).Of the 96 patients, 50 patients (44 males and 52 females) average age at the time of surgery was 82 years (range 65¿99 years) comprise the final study group.These patients were treated with a proximal femoral nail (pfn; proximal femoral nail antirotation (pfna), ao synthes) alone (group 1) without any other anti-osteoporosis treatment.These patients were compared with 46 patients for whom the same device was used and a weekly subcutaneous injection of 56.5 mg teriparatide (pth 1-34, teribone) was prescribed postoperatively for 8 weeks (group 2).Patients were seen for follow-up at 4, 8, 12, 16, 20, and 24 weeks and then every 6 months thereafter, with clinical and radiographic evaluations.All patients were seen by the authors at an outpatient clinic.The following complications were reported as follows: two patients , who were lost to follow-up, died.Group 1: 2 cases of reduction loss.1 case of deep wound infection.2 cases superficial wound infection.4 cases of malunion.Group 2: 2 cases of superficial wound infection.5 cases of malunion.Excessive screw sliding occurred in one patient in group 1.Excessive screw sliding occurred in one patient in group 2, who required further intervention because of severe skin irritation (screws were exchanged).Loss of reduction with screw sliding occurred in two patients, who were reoperated for a bipolar hip replacement.This is report 1 of 5 for pc-(b)(4).This report is for an unknown synthes femoral nail antirotation (pfna) construct.

• Brand Name: UNK - CONSTRUCTS: PFNA
• 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: 9616022
• MDR Text Key: 189566321
• Report Number: 8030965-2020-00534
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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
• Date Manufacturer Received: 12/30/2019
• 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