MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM CORAIL

Catalog Number UNK HIP FEMORAL STEM CORAIL

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Sepsis (2067); Perforation of Vessels (2135); Post Operative Wound Infection (2446); Thromboembolism (2654); Limb Fracture (4518); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled ¿orthopaedic residents¿ autonomy in hip fracture surgery: what is the effect on patient outcomes?" written by dan prat, or maoz, c.Lucas myerson, amit zabtani, arnon afek, shay tenenbaum, published by archives of orthopaedic and trauma surgery, 19 december 2020, was reviewed.The articles purpose was to determine if surgery performed solely by residents, without supervision or participation of an attending surgeon, can provide similar outcomes to surgery performed by trauma or joint reconstruction fellowship-trained orthopaedic surgeons.In the context of growing prevalence of hip fractures and hip fracture surgery in the elderly, it is unknown if surgical trainee autonomy in the operating room conflicts with optimal health care provision and safety of patients.A single-center cohort was retrospectively reviewed for all hip fracture cases, surgically treated with hemiarthroplasty or internal fixation during 2016.Data were analyzed and compared between surgery performed solely by post-graduate year 4 to 6 residents, and surgery performed by trauma or joint replacement fellowship-trained surgeons.Demographics, time to surgery, and american society of anesthesiologists physical status classifcation system (asa), surgical parameters, preoperative and postoperative radiographs as well as primary (mortality, complications and revision surgery) and secondary outcome variables were collected and analyzed.Univariate analysis and kaplan¿meier survival analysis were performed to evaluate outcomes.Results out of 478 cases, 404 were included in this study.Non-operative cases, techniques used solely by attending surgeons, such as total hip replacement, were excluded.The average follow-up time was 26.1 months.Analysis of internal fixation and hemiarthroplasty groups demonstrated no significant difference between residents and attendings in complications and mortality.In both groups, surgery time was significantly longer in the resident group.The current study demonstrates that hip fracture surgery performed by adequately trained orthopaedic surgery residents can provide similar results to surgery performed by fellowship-trained attendings.This study contained depuy corail hip systems and synthes proximal nail anti-rotation (pfna), dynamic hip screw (dhs) and fixations screws.Adverse events for the corail hip system, which is composed of cup/liner/head/stem: surgery prolonged, blood transfusion required, 3 revision were for periprosthetic fractures, 4 revisions for unspecified reasons, mortality 10 within 30 days of surgery.36.7% of patients had major (30.1%) or minor (16.5%) complications: these were listed as major: deep infection, vte, myocardial infarction, cerebrovascular accident, arrhythmia, pneumonia, congestive heart failure.Minor: superficial wound infection, delirium, urinary tract infection, ileus, and bedsores.Adverse events for synthes has been captured by synthes complaint.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12368120
• MDR Text Key: 268246993
• Report Number: 1818910-2021-18667
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/07/2021

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
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention