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

Catalog Number 320-10-00

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/30/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: serial number item number and full description: (b)(6) ,300-30-09 - equinoxe preserve stem 9mm; (b)(6), 320-31-36 - glenosphere, 36mm; (b)(6), 320-35-08 - small superior/posterior augglenoid plate,right; (b)(6) 320-36-00 - 145-deg pe 36mm hum liner +0.

Event Description

It was reported via clinical study, that during/intra-op the initial implant, this 69 yo female patient experienced a coracoid scapular fracture.The coracoid block loosened and gps abandoned.Upon gh joint reduction the tip of the coracoid fractured with mild displacement.The patient¿s outcome was last known as continuing.The case report form indicates this event is possibly related to device and definitely related to procedure.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: 17581168
• MDR Text Key: 321518983
• Report Number: 1038671-2023-01989
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• 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: 08/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White