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

Catalog Number UNK - CONSTRUCTS: PFNA-II

Device Problem No Apparent Adverse Event (3189)

Patient Problems Calcium Deposits/Calcification (1758); Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown unk - constructs: pfna-ii/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: zhang, h.Et al (2017), intertan nail versus proximal femoral nail antirotation-asia for intertrochanteric femur fractures in elderly patients with primary osteoporosis, journal of international medical research, vol.45 (4), pages 1297-1309 (china).The aim of this retrospective comparative study is to compare the clinical and radiographic outcomes of the it and pfna-ii in the management of iffs (ao/ota type 3.1a1.1-a2.3) in elderly patients with osteoporosis during a minimum 3-year follow-up period.Between january 2009 to march 2012, a total of 243 patients were included in the study.Of these, only 88 patients (34 male and 54 female) with a mean age of 74.6±6.3 years were treated with proximal femoral nail antirotation-asia (pfna-ii) (synthes, solothurn, switzerland) while 86 patients (30 male and 56 female) with a mean age of 72.7±7.6 years were treateds with a competitor's device.Follow-up assessments were performed 1, 3, 6, 9, and 12 months postoperatively and every year thereafter.Follow-up period was an average of 40 months (range, 38¿60 months).The following complications were reported as follows: 10 patients died (5 due to cerebrovascular accident, 4 due to lung cancer, and 1 due to gastric cancer).A total of 24% of patients in the pfna-ii group described some level of hip pain in the resting state, and this proportion increased to 43% in the active state.1 patient had periprosthetic fracture.1 patient had lateral cortex fracture.8 patients had femoral shaft fracture after implant removal.1 patient had delayed union.1 patient had nonunion.1 patient had femoral head offset.2 patients had lower limb shortening (>1.5 cm) 1 patient had complications of distal interlocking.1 patient had heterotopic ossification.6 patient had implant failure: 4 patients had screw cut-out, which cannot be adjusted or repaired, and 2 were experiencing unbearable pain due to an unstable fracture (ao/ota type 31a2.2 and a2.3) with medial calcar damage, without bone grafting during the operation.Revision surgery was performed as quickly as possible, without waiting for the situation to further deteriorate.1 patient had prosthetic instability.2 patients had screw cut-out.1 patient had migration of proximal screw(s).This impacted product captures the following adverse events: hip pain.Periprosthetic fracture.Lateral cortex fracture.Femoral shaft fracture after implant removal.Delayed union.Nonunion.Femoral head offset.Lower limb shortening (>1.5 cm) complications of distal interlocking.Heterotopic ossification.This report is for an unknown synthes pfna ii construct and unknown synthes screws.This report is 1 of 4 for (b)(4).

• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9567059
• MDR Text Key: 189168997
• Report Number: 8030965-2020-00175
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PFNA-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• 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