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

Catalog Number 320-06-38

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: humeral stem or stemless.Reverse humeral liner 320-38-03.Reverse humeral tray 320-10-00.Reverse glenosphere baseplate 320-15-06.

Event Description

It was reported via clinical study, that approximately 2 years postop the initial implant, this 64 yo female patient experienced migration of anchor or screw.X-ray results showed new fracture through the most inferior glenosphere screw.The patient remains asymptomatic and will return in 3 months for re-evaluation.The outcome was last known as continuing.Devices will not be returned.

• 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: 17461788
• MDR Text Key: 320421368
• Report Number: 1038671-2023-01863
• 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: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2023

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: 320-06-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American