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

Catalog Number	314-13-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) - 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.(b)(6) - 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6) - 300-20-02 - equinox square.Torque define screw drive kit.(b)(6) - 310-01-41 - equinoxe, humeral head short, 41mm (alpha).(b)(6) - 314-13-02 - equinoxe cage glenoid small, alpha.(b)(6) - 315-35-00 - glnd kwire.
Event or Problem Description
As reported, approximately 2 months and 2 days post the initial atsa, the patient was revised with an antibiotic spacer.The spacer was replaced with reverse shoulder components on (b)(6) 2016.No other information reported.

• Brand Name: EQUINOXE ANATOMIC SHOULDER SYSTEM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19446265
• Report Number: 1038671-2024-01676
• Device Sequence Number: 3214141
• Product Code: KWS
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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 Age: 72 YR
• Patient Sex: Female