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

Catalog Number	314-13-13
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 5 years 2 months post op.This was a revision of a stemless atsa, legacy cage glenoid failure and poly wear.Removal of exactech stemless atsa with legacy cage glenoid, poly/liner failure and extreme poly wear, disassociation from pegs.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-62-02 - stemless humeral comp integrip, cage, size 2, (b)(6); 310-61-47 - stemless humeral head 47mm x 18mm x beta, (b)(6); 319-01-32 - steinmann pin sterile 3.2mm x 178mm, (b)(6); 315-35-00 - glnd kwire, (b)(6).
Additional Manufacturer Narrative
The revision reported was likely due to prosthesis wear and fracture of the caged glenoid as reported.The cause of these failures may be due to incomplete seating of the implant and/or off-axis drilling of the peg holes during implantation leading to a rocking horse effect around a well-fixed cage.However, the series of events could not be confirmed as the devices were not returned for evaluation.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.H6: corrected medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 3523771140
• MDR Report Key: 20599783
• Report Number: 1038671-2024-04219
• Device Sequence Number: 8797208
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2024
• Device Catalogue Number: 314-13-13
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 03/13/2019
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male