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

Catalog Number 300-30-06

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported via clinical study that the 55 yo female patient experienced a humeral fracture and crack in calcar when broaching for humeral stem.The outcome was last known as continuing.

Manufacturer Narrative

D10.Concomitants: 320-36-00 - 36mm humeral liner +0 unconstrained.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-31-36 - glenosphere, 36mm.320-35-02 - small superior augment glenoid plate.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• 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
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16998670
• MDR Text Key: 315906832
• Report Number: 1038671-2023-01120
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White