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

Device Problems Degraded (1153); Material Discolored (1170); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Type  Injury  

Event Description

(b)(6) underwent total shoulder replacement with the equinoxc implant on (b)(6) 2014.During the following years, she suffered continued pain in the shoulder and underwent exploratory surgery of the shoulder on (b)(6) 2022.The surgeon found that the glenoid portion of the implant was discolored and delaminating and that pieces of plastic had broken off the glenoid portion of the implant.The surgeon states that the glenoid portion of the implant will need to be replaced in the coming months.

• Brand Name: EQUINOXE SHOULDER SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 15638467
• MDR Text Key: 302197495
• Report Number: MW5112747
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM; COLACE; FAMOTIDINE; LORAZEPAM; TUMERIC; VITAMIN B12; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White