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

Model Number	EQUINOXE CAGE GLENOID MEDIUM, ALPHA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4243603 - 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.4008861 - 300-10-15 - equinoxe replicator plate 1.5mm o/s.4231975 - 300-20-02 - equinox square torque define screw drive kit.3850838 - 310-01-47 - equinoxe, humeral head short, 47mm (beta).3693572 - 14-13-03 - equinoxe cage glenoid medium, alpha.4201245 - 315-35-00 - glnd kwire.
Event or Problem Description
It was reported that a male patient, initial right shoulder implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2024, approximately 7 years 11 months post the initial procedure.The patient had a previous total shoulder replacement then failed rotator cuff which required the change to a reverse shoulder replacement.Everything was removed.Image of device provided appeared to be fractured which was reported to be found upon opening the wound site.There were no device breakages or surgical delays during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.The explanted devices are not available for analysis as they were discarded at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of the patient¿s rotator cuff tear.The reason for the observed fracture of the glenoid component could not be determined since the device was not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19153877
• Report Number: 1038671-2024-00922
• Device Sequence Number: 7443986
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2019
• Device Model Number: EQUINOXE CAGE GLENOID MEDIUM, ALPHA
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male