MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-34
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via experience report that "the patient was revised due to infection." the right side was affected.All implants were removed.There was no reported surgical delay.Initial implant date: (b)(6) 2023.Revised on (b)(6) 2024.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Product not returning: disposed.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-30-09 - equinoxe preserve stem 9mm, (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta), (b)(6), 314-13-34 - equinoxe cage glenoid l, post aug, right, (b)(6), 315-35-00 - glnd kwire, (b)(6), 531-78-20 - shouldr gps hex pins kit, (b)(6), 531-78-20 - shouldr gps hex pins kit, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), a10012 - gps implant kit v2.
Additional Manufacturer Narrative
Results of investigation: a review of the sterile certificates for the implanted devices was performed.All lots were accepted to the requirements.The reason for the revision reported was likely due to an infection.However, the reason for the infection cannot be conclusively determined based on the information provided.Infection is a known potential surgical complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: g4 - pma/510(k)number, d4 - expiration date, h4 the following sections were corrected: a2, b5, d1, d2a, d2b, d4, d6b, d10 concomitants: (b)(6) a10012 - gps implant kit v2 (b)(6) 314-13-34 - equinoxe cage glenoid l, post aug, right (b)(6) 310-01-47 - equinoxe, humeral head short, 47mm (beta) (b)(6) 300-20-02 - equinox square torque define screw drive kit a137506 300-30-09 - equinoxe preserve stem 9mm (b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s (b)(6) 531-78-20 - shouldr gps hex pins kit (b)(6) 531-78-20 - shouldr gps hex pins kit (b)(6) 315-35-00 - glnd kwire h6 - health effect - clinical code, medical device problem code.
Event or Problem Description
It was reported that this patient underwent an initial tsa (total shoulder arthroplasty).Subsequently, the patient developed poly wear then developed infection due to a biopsy.As a result, the surgeon revised everything and a cement spacer was placed 6.5 years post operation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, h4, h6.
Event or Problem Description
As reported, approximately 2 years and 2 months post the initial right total shoulder arthroplasty, the patient was revised due to a loose glenoid component with marked osteolysis of the glenoid due to polyethylene wear.Everything was removed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6.The following sections were corrected: b4, b5, h6.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• 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: julia gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19893068
• Report Number: 1038671-2024-02657
• Device Sequence Number: 7254615
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/08/2026

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: 02/02/2025
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 07/15/2025; 10/31/2025; 10/31/2025; 08/19/2026
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 11/01/2024; 07/30/2025; 11/05/2025; 11/20/2025; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male