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

Catalog Number 320-01-38

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

Patient Problem Implant Pain (4561)

Event Date 07/04/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: reverse glenosphere baseplate 3201504.Humeral stem or stemless 3000113.Reverse humeral liner 3203803.Reverse humeral tray 3201000.

Event Description

It was reported via clinical study, that approximately 18 months postop the initial implant, this 73 yo male patient was experiencing severe pain for 2 months.X-ray result shows an aseptic glenoid loosening.Patient was prescribed soft rehabilitation involving shoulder and spine as he suffers from cervical spine pathology which could explain the pain.The patient¿s outcome was last known as continuing.The case report form indicates this event is unlikely related to device and definitely not related to procedure.Devices will not be returned.

Manufacturer Narrative

Section h10: (h3) the pain reported may be due to a combination of aseptic (non-infected) glenoid loosening and the patient¿s cervical spine pathology.However, this cannot be confirmed because no radiographs were provided, and the patient has not been revised.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17475891
• MDR Text Key: 320569323
• Report Number: 1038671-2023-01886
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 93 KG