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

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

Patient Problems Extravasation (1842); Hematoma (1884); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: fernandes, p.X.Et al (2019), injury to the superior gluteal artery during intramedullary fixation of a proximal femoral fracture ¿ a case report, journal of orthopaedic case reports, vol.9 (6), pages 27-31 (portugal).This study presents a case report of a 66 -year-old female patient who sustained a right pertrochanteric fracture after a low-energy fall from a standing height.She underwent a closed reduction and long intramedullary nail fixation.Surgery was performed using an anterograde long femoral nail (proximal femoral nail antirotation; synthes®oberdorf, switzerland), with a caputcollum-diaphyseal angle of 125°, 380mm in length, and 10mm in diameter.On the 1st post-operative day, the patient developed an extensive ecchymosis of the thigh, attributed to the normal evolution of the fracture hematoma.She was transfused with two units of packed red blood cells (prbcs), with an appropriate rise of hemoglobin level from 5.6g/dl to 9.2g/dl.She remained hemodynamically stable and began rehabilitation 2 days after surgery.Surgical dressings remained clean and dry.Two supplementary units of prbcs were administered for persistent anemia on post-operative day 3, without evidence of increased swelling or ecchymosis.The patient general condition was stable.However, pain and diffuse swelling of the thigh were not alleviated and, on post-operative day 5, there was an abrupt drop in hemoglobin level to 5g/dl, without evidence of gastrointestinal or urinary tract bleeding, neurological signs, or abdominal pain.She was transfused with two additional units of prbcs and transferred to the intermediate care unit for monitoring.The thigh was recognized to be swollen but not tense.The patient underwent a computed tomography (ct) scan of the right hip, which demonstrated an extensive hematoma in the region of the gluteus medius, measuring 25 ×7cm (fig.2).On the following day, a ct scan with contrast showed no significant change in the dimensions of the hematoma but revealed findings suggestive of an active contrast extravasation in the gluteal region (fig.3).Angiography was subsequently performed, on post-operative day 7, and confirmed an active extravasation of contrast from the right superior gluteal artery that was coiled and embolized (fig.4, 5, 6).The patient was discharged on post-operative day 25, after the treatment of urinary tract infection caused by klebsiella extended-spectrum betalactamases.After discharged clinical deterioration occurred and the patient died of metastatic cancer 3 months after surgery.This report is for an unknown synthes pfna constructs.It captures the reported events of developed an extensive ecchymosis of the thigh, increased swelling or ecchymosis, pain and diffuse swelling of the thigh, extravasation of contrast from the right superior gluteal artery, and uti this is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11366172
• MDR Text Key: 239819295
• Report Number: 8030965-2021-01256
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/23/2021
• 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: 66 YR