MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-00
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: a536080 300-01-13 - equinoxe, humeral stem primary, press fit 13mm a454269 320-06-46 - glenosphere 46mm a579799 320-10-00 - equinoxe reverse tray adapter plate tray +0 a591043 320-15-04 - rs glenoid plate r post aug, 8 deg, right a538272 320-15-05 - eq rev locking screw a560839 320-20-00 - eq reverse torque defining screw kit s450961 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm s450978 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm a111365 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.
Event or Problem Description
It was reported that this 73 y/o patient's right shoulder was revised approximately 9 months post op.After xray it was determined the poly disassociated from the tray.They are not sure when the event occurred but the patient came to the doctors office with pain and clicking.The tray was removed and the glenosphere taken off to evaluate the stem and glenoid plate.Both were found to be well fixed.Then the surgeon trialed a 42+4 and found it to have excellent rom.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The revision reported may have been due to disassembly.However, the reported disassembly could not be confirmed.Potential contributions of user and patient-related considerations to the event, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.B3: corrected.D6: corrected.H6: corrected.Health effect, medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +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: 19243920
• Report Number: 1038671-2024-01050
• Device Sequence Number: 7107831
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 320-46-00
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2022
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown