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 Dyspnea (1816); Bone Fracture(s) (1870); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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

Literature article entitled ¿presurgical optimization and opioid-minimizing enhanced recovery pathway for ambulatory knee and hip arthroplasty: postsurgical opioid use and clinical outcomes" written by alaine van horne and james van horne, md.Published by arthroplasty today published online/accepted by publisher 20 august 2019 was reviewed.The article's purpose was to performs a retrospective review of ¿outcomes from an eras pathway designed to maximize patients¿ eligibility for ambulatory tka/tha while reducing costs, complications, and postsurgical opioid use.¿ data was compiled relating to 220 unique, consecutive patients who underwent 251 total knee arthroplasty or total hip arthroplasty surgeries (tka 113, tha 138).No patient was excluded from the analyses.Patients¿ mean age was 58 (22-84) years, 49% were women, 51% were men.27 patients had medical history of heart disease, and 15 patients had a medical history of diabetes.Specific patient identifiers were not provided.Cement manufacturer was not identified.Depuy products: sigma total knee construct and corail stem and pinnacle cup construct.Total knee adverse events (all occurring within 60 days of operation): deep wound infection ¿ required surgical intervention, ulcer/gastrointestinal complication, pain, back pain, shortness of breath.Total hip adverse events (all occurring within 60 days of operation): deep wound infection ¿ required surgical intervention, bone fracture ¿ required surgical intervention, dislocation ¿ required surgical intervention, pain, urinary tract infection, severe constipation, back pain, shortness of breath.

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: 11108258
• MDR Text Key: 233127981
• Report Number: 1818910-2021-28159
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention