MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-30-08 - equinoxe preserve stem 8mm: (b)(6).315-35-00 - glnd kwire: (b)(6).320-06-42 - glenosphere 42mm: (b)(6).320-15-01 - eq rev glenoid plate: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev comp scr lck cap kit, 4.5 x 18mm: (b)(6).320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6).320-31-40 - glenosphere, 40mm: (b)(6).531-55-88 - ergo gps 3.2mm drill kit sterile: (b)(6).531-78-20 - shouldr gps hex pins kit: (b)(6).(b)(6).- gps implant kit v2: 10010722004 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
As reported, approximately 2 years and 7 months post the initial left reverse total shoulder arthroplasty, the patient complained of pain and was revised due to poly disassociation.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.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23907212
• Report Number: 1038671-2025-03635
• Device Sequence Number: 9194827
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• 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
• Report Date (Section B): 12/29/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-10-00
• 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: 12/29/2025
• Initial Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 02/08/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male