MAUDE Adverse Event Report: EXACTECH, INC. EQUONOXE REVERSE GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-12 - equinoxe preserve stem 12mm: 5186807, 320-42-00 - equinoxe reverse 42mm humeral liner +0: 5577360, 320-10-00 - equinoxe reverse tray adapter plate tray +0: 5758235, 320-01-42 - equinoxe reverse 42mm glenosphere: 5570919.
Event or Problem Description
Approximately 5 year(s), 4 month(s) and 27 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening - severe osteolysis behind baseplate.It was further reported that this produced persistent / significant disability and medical / surgical intervention was necessary.The patient underwent standard reverse revision with the removal of the torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw, glenoid baseplate, and compression screw / locking cap.The outcome of this event is considered continuing, and the clinical report indicates that this event is unlikely related to the device(s) and definitely related to the procedure.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of glenoid loosening.However, the reported glenoid loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.H6: corrected investigation clinical codes.

• Brand Name: EQUONOXE REVERSE GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 ; 3523771140
• MDR Report Key: 20547367
• Report Number: 1038671-2024-04142
• Device Sequence Number: 15421966
• Product Code: KWS
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/08/2025

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 Expiration Date: 08/08/2026
• Device Catalogue Number: 320-15-04
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 04/08/2025
• Date Device Manufactured: 08/08/2016
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White