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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 1 month post the initial right total shoulder arthroplasty, the patient went to wash their hair and felt a pop and pain.On examination of an x-ray it showed that there were multiple fixation screws broken behind the glenoid plate.The patient was revised.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
300-30-06 - equinoxe preserve stem 6mm (b)(6), 320-06-42 - glenosphere 42mm (b)(6), 320-15-05 - eq rev locking screw (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm (b)(6), 320-42-03 - equinoxe reverse 42mm humeral liner +2.5 (b)(6).No device was returned for evaluation; the reported event was confirmed by review of radiograph images provided.The review identified that based on the pre-revision x-rays provided, the glenosphere/glenoid baseplate constructs appears to be displaced from the original implanted position.It is difficult to ascertain from the views in the provided radiograph if there were any radiolucencies around the center cage or if the baseplate was not fully seated at the time of implantation that would indicate that the glenoid baseplate did not achieve long-term fixation, subsequently causing the compression screws to bear the joint load and eventually fracture.Due to the limited information provided, it is not possible to determine the root cause of the glenoid baseplate loosening and subsequent compression screw fracture.Possible root causes include improper seating of the baseplate, trauma, insufficient bone grafting behind the glenoid baseplate, infection, risk factors that could impact bone healing such as smoking, or any combination of these possibilities.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the glenoid baseplate not achieving long-term fixation, causing the compression screws to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to determine the root cause of the insufficient glenoid baseplate fixation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: katy priest ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25281092
• Report Number: 1038671-2026-00648
• Device Sequence Number: 21273658
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• 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: 2021
• 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): 05/26/2026

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 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: 09/12/2022
• Initial Report FDA Received Date: 05/26/2026
• Date Device Manufactured: 06/07/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male