MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-36-00

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

Patient Problem Pain (1994)

Event Date 10/01/2023

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, the 63-year-old non-hispanic white female had a right tsa on (b)(6) 2022.The patient presented with sub-acromial impingement on (b)(6) 2023.Patient noticed increased pain with overhead activity without inciting event.The event reported a revision with no date and the outcome is considered continuing.The case report form indicates that this event is possibly 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

(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-31-36 - glenosphere, 36mm.320-35-02 - small superior augment glenoid plate.(h3) pending evaluation.

• Brand Name: EQUINOXE 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19218099
• MDR Text Key: 341457880
• Report Number: 1038671-2024-01019
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/30/2024

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: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• 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
• Removal/Correction Number: Z-1415-2024
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White