MAUDE Adverse Event Report: EXACTECH, INC. Equinoxe Shoulder System; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	314-02-14
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Insufficient Information (4580)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 11 years after a right total shoulder replacement, surgeon decided patient indications necessitated revision shoulder arthroplasty.Surgeon explanted in-situ implants: all poly glenoid, humeral head, replicator plate and torque defining screw.Surgeon implanted new replicator plate, torque defining screw and humeral head.Event is not related to the breakage of a device.Event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Product not returning: hospital retains the products.No further information provided.
Additional Manufacturer Narrative
D10: concomitants: 2543128 300-10-15 - equinoxe replicator plate 1.5mm o/s 2628749 300-20-02 - equinox square torque define screw drive kit 2682596 310-02-50 - equinoxe, humeral head tall, 50mm (beta).

• Brand Name: Equinoxe 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19621083
• Report Number: 1038671-2024-02162
• Device Sequence Number: 12883312
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 09/22/2026

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: 04/02/2018
• Device Catalogue Number: 314-02-14
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2013
• 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: 77 YR
• Patient Sex: Male