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 Codes	Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 320-02-42 - rev expd glenosphere 42mm, +4mm offset: (b)(6).320-42-03 - equinoxe reverse 42mm humeral liner +2.5: (b)(6).320-42-03 - equinoxe reverse 42mm humeral liner +2.5: (b)(6).300-01-15 - eq humeral stem primary, press fit 15mm: (b)(6).300-01-15 - eq humeral stem primary, press fit 15mm: (b)(6).320-10-00 - equinoxe tray adapter plate tray +0: (b)(6).320-10-05 - equinoxe tray adapter plate tray +5: (b)(6).320-15-02 - rs glenoid plate sup aug, 10 deg: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev cmprss scr lck cap kit, 4.5 x 18mm: (b)(6).320-20-22 - eq rev cmprss scr lck cap kit, 4.5 x 22mm: (b)(6).320-20-26 - eq rev cmprss scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev cmprss scr lck cap kit, 4.5 x 30mm: (b)(6).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.A definitive root cause was unable to be determined; however, may have resulted from humeral tray disassociation, likely leading to the reported humeral liner disassociation and glenosphere loosening.The humeral tray disassociation may have been the result of incomplete seating/cross-threading of the reverse torque defining screw and/or an unreported post traumatic event, which allowed the torque defining screw to back out.The glenosphere loosening may have been the result of abnormal articulation following the humeral liner/tray disassembly, incomplete seating of the glenosphere locking screw and/or the glenosphere on the baseplate at the time of implantation, or a combination of these possibilities.Following the humeral tray and liner disassociation, abnormal articulation between the metal components likely resulted in the reported noise.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 approximately six years after a reverse right total shoulder replacement the patient experienced pain.The patient underwent a right total shoulder revision procedure due to disassociation of the humeral tray, humeral liner, glenosphere and locking screw.No medical or surgical interventions were reported.No additional information is available.

• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23351041
• Report Number: 1038671-2025-03161
• Device Sequence Number: 12975187
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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 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: 12/22/2022
• Initial Report FDA Received Date: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White