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

Catalog Number	320-20-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-40-03 - humeral liner, 40mm, +2.5, (b)(6) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(6) 320-15-05 - eq rev locking screw, (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6) 320-31-40 - glenosphere, 40mm, (b)(6) 320-35-02 - small superior augment glenoid plate, (b)(6) 321-20-00 - equinoxe reverse shoulder drill kit.Multiple mdr reports were filed for this event, please see associated reports: mfr#1038671-2025-01992.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the left side.Subsequently, approximately 5 years later the patient noted feeling a pinch in their left shoulder followed by intense pain and inability to raise their arm.The patient went to the emergency room and discovered the humeral tray had detached from the humeral stem.The patient noted they did not experience any form of trauma to the prosthesis.Revision surgery has been scheduled.No further patient impact was provided.No additional is available at this time.

• Brand Name: EQUINOXE REVERSE TORQUE DEFINING SCREW KIT
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21978495
• Report Number: 1038671-2025-01993
• Device Sequence Number: 17948862
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 12/08/2024
• Device Catalogue Number: 320-20-00
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 12/10/2019
• 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: 67 YR
• Patient Sex: Unknown