MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-38-03

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

Patient Problem Failure of Implant (1924)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: a015422 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.A010059 320-10-00 - equinoxe reverse tray adapter plate tray +0.6613724 320-08-38 - glenosphere exp 38mm +4mm offset a004814 320-15-01 - eq rev glenoid plate.

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2022.The patient presented on (b)(6) 2022 and reported increased right shoulder pain on (b)(6) 2022.Ct scan done with negative new pathology.Injection given on (b)(6) 2022.Given medrol dosepak with somewhat improvement.The case report form indicates that this event is definitely not related to device, possibly related to procedure.Outcome: resolved on (b)(6) 2023.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +2.5
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18065039
• MDR Text Key: 327278906
• Report Number: 1038671-2023-02671
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White