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

Catalog Number 314-13-03

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported via a voluntary medwatch, that a patient, initial right shoulder implanted on (b)(6) 2020, underwent a revision procedure on (b)(6) 2024, approximately 3 years 6 months post the initial procedure.Around the fall of 2022, the patient started to experience pain in their right shoulder and right arm.Gradually, the pain worsened, and they contacted the orthopedic surgeon who did the replacement in early 2024.They could feel and hear grinding in their shoulder with movement and were concerned something was wrong.They had imaging done via their orthopedic surgeon and was told the screws looked like they had loosened.They completed 2 months of therapy, with no relief.After repeat imaging later in 2023, the surgeon told them that it looked like the glenoid part of their replacement failed.They were given options, all including different surgeries.They chose to have the failed, fractured portion surgically removed only.During the surgery, it was discovered that the prosthetic socket was fractured, with all 5 screws loose, and that the inside of their shoulder joint was black from the grinding of the prosthesis and the screws.Unfortunately, 3 of the screws floated into their tissues and were unable to be safely removed because of their location to nerves.Because of this, they lost over a year of quality of life, as they are right-hand dominant and were unable to complete simple tasks like opening car doors, dressing without pain, house chores, etc.Since the removal of the failed glenoid prosthesis, the patient¿s pain has improved, but they continue to have pain to this day and are still completing physical therapy, amongst follow-up visits with their orthopedic surgeon.No further information.

Manufacturer Narrative

Section h10: (h3) pending evaluation.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19122493
• MDR Text Key: 340340384
• Report Number: 1038671-2024-00881
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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: 314-13-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• 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
• Treatment: UNK.