MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-05
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5 (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), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6), 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm (b)(6), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm (b)(6), 320-42-00 - equinoxe reverse 42mm humeral liner +0 (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01190.The revision reported in this event was likely the result of a combination of dislocation and humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation-which may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient conditions, or any combination of these possibilities-led to the dislocation as the explanted devices were not returned for evaluation and images/pre-revision radiographs were unable to be obtained.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.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
Report 2 of 2 of this event.As reported a patient underwent an initial left reverse total shoulder arthroplasty.Subsequently, the patient experienced dislocation.As a result, seven (7) years later, the patient was revised.The poly was disassociated from the tray.Patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.The revision reported in case- (b)(4) was likely the result of a combination of dislocation and humeral liner disassociation.It is unclear if the dislocation allowed for the humeral liner to disassociate or if the humeral liner disassociation-which may have been the result of either incomplete seating of the liner during implantation, bone impingement, patient conditions, or any combination of these possibilities-led to the dislocation as the explanted devices were not returned for evaluation and images/pre-revision radiographs were unable to be obtained.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• 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 ct; gainsville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 24105465
• Report Number: 1038671-2026-00056
• Device Sequence Number: 13315710
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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): 01/17/2026

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: 06/23/2023
• Device Catalogue Number: 320-10-05
• 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: 09/09/2022
• Initial Report FDA Received Date: 01/17/2026
• Date Device Manufactured: 06/06/2015
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 102 KG