MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM GLENOSPHERE

Model Number 320-01-42

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/06/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 320-15-08, sup/post aug plate, r rs glenoid baseplate ,320-15-05, eq rev locking screw ,320-20-00, eq reverse torque defining screw kit ,300-01-13, equinoxe, humeral stem primary, press fit 13mm ,320-10-00, equinoxe reverse tray adapter plate tray +0 ,320-42-13, equinoxe reverse 42mm humeral const liner +2.5 , and 315-35-00, glnd kwire.

Event Description

As reported, approximately 2 days postop the initial procedure, the (b)(6) male patient had a right shoulder peri prosthetic fracture post-op so the surgeon cabled the fracture and put new implants in.Patient was last known to be in stable condition following the event.Devices not being returned due to facility policy.

Manufacturer Narrative

(h3) upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or loosening of total joint hardware.The most likely cause of the reported event was a malunion of a fracture which was likely caused by over-reaming during implantation.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM GLENOSPHERE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12913452
• MDR Text Key: 286441887
• Report Number: 1038671-2021-00652
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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 Model Number: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male