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

Catalog Number 320-35-08

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 300-30-08 - equinoxe preserve stem 8mm, 320-36-00 - 36mm humeral liner +0 unconstrained, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 320-35-08 - small superior/posterior augglenoid plate,right.

Event Description

It was reported via clinical study that the 70 yo female patient experienced a scapular spine fracture (type 2).The patient was unaware that she had the acromial stress fracture.There was no trauma.The patient was asymptomatic.The outcome was last known as continuing.

• 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: 16999256
• MDR Text Key: 315911186
• Report Number: 1038671-2023-01125
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534927
• UDI-Public: 10885862534927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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: 05/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Race: White