MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-13-03

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 01/11/2024

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2018.The patient was revised on (b)(6) 2024 due to rotator cuff failure.The equinoxe anatomic was converted to an equinoxe reverse.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

H3: pending investigation.D10: 5258477-300-01-13 - equinoxe, humeral stem primary, press fit 13mm.5045987-300-10-15 - equinoxe replicator plate 1.5mm o/s.4968187-300-20-02 - equinox square torque define screw drive kit.5131701-310-01-44 - equinoxe, humeral head short, 44mm (alpha) 3693545-314-13-03 - equinoxe.Cage glenoid medium, alpha 5130583-315-35-00 - glnd kwire.

Manufacturer Narrative

The revision reported was likely the result of rotator cuff failure, which may have contributed to the prosthesis wear.The extent and root cause of the prosthesis wear and rotator cuff failure cannot be determined as the devices were not returned for evaluation.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18622871
• MDR Text Key: 334324125
• Report Number: 1038671-2024-00145
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2024

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 Expiration Date: 08/26/2019
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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
• Patient Sex: Female