MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID, PEGGED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 9999

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.

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 aseptic glenoid loosening on 03-23-2017.It was reported the patient had pain since more than 1 year fall at work on 03/22/2017.Ct-scan shows glenoid loosening.This case is related to case-2024-00012634, case-2024-00012636.The patient underwent the action of standard total revision surgiery on (b)(6) 2017.The outcome of this event is considered resolved.The case report form indicates that this event is unlikely related to the device and definitely not related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• Brand Name: EQUINOXE GLENOID, PEGGED
• 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: 19112436
• MDR Text Key: 340233340
• Report Number: 1038671-2024-00854
• 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: 03/29/2024
• 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