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

Catalog Number 320-15-07

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

D10.Cocomitants: 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.320-42-03 - equinoxe reverse 42mm humeral liner +2.5.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-01-42 - equinoxe reverse 42mm glenosphere.

Event Description

It was reported via clinical study that the 66 yo female patient experienced aseptic glenoid loosening and gradual baseplate loosening with broken screw.No specific mechanism was noted.The date of onset is (b)(6) 2022.The patient was revised on (b)(6) 2022.The outcome was last known as resolved.

• 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.; FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17452205
• MDR Text Key: 320322952
• Report Number: 1038671-2023-01123
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862242556
• UDI-Public: 10885862242556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131575
• 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: 08/03/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 08/03/2023
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White