MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 46MM GLENOSPHERE

Model Number 320-01-46

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 04/11/2018

Event Type  Injury  

Event Description

As reported, approximately 5 months postop the initial right tsa, this(b)(6) male presented with broken screws in the right shoulder and was revised approximately 3 months later.At that time, the outcome was reported as resolved.The case report form indicates this event is definitely related to devices and possibly related to procedure.This event report was received through clinical data collection activities.Devices were not returned per study protocol.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, 320-46-00 - equinoxe reverse 46mm humeral liner +0, 320-10-00 - equinoxe reverse tray adapter plate tray +0, and 320-15-04 - rs glenoid plate r post aug, 8 deg, right.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of breakage of one or more of the screws used.However, not enough information was provided to determine which screw(s) fractured or the cause of the fracture.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 46MM 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: 13003559
• MDR Text Key: 285705089
• Report Number: 1038671-2021-00697
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086402
• UDI-Public: 10885862086402
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: 320-01-46
• Device Catalogue Number: 320-01-46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/11/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White