MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 9999

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

Patient Problem Pain (1994)

Event Date 03/15/2016

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 44-year-old white male had a right tsa on (b)(6) 2009.The patient present with unexplained pain on (b)(6) 2016.It was reported as osteophyste above metaglene.This case is related to case (b)(4) , case (b)(4).The patient underwent the action of acromioplasty under arthroscopy and the event is considered resolved on 03-15-2016.The case report form indicates that this event is definitely not related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

Manufacturer Narrative

(h3) pending evaluation.

• Brand Name: EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19111698
• MDR Text Key: 340226421
• Report Number: 1038671-2024-00844
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White