MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 4 year(s), 1 month(s) and 6 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening with pain and increasing radiolucency's/osteolysis on imaging.The patient underwent standard reverse revision surgery with the removal of the humeral tray, humeral liner, glenoshpere locking screw, and compression screw/locking cap.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely related to the device(s) and possibly related to the procedure.
Additional Manufacturer Narrative
(d10): concomitant device(s): 300-01-12 - equinoxe humeral stem primary press fit 12mm: (b)(6) 315-35-00 - glnd kwire: (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0: (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) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: (b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0: (b)(6).
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.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.D1: corrected.D4: corrected.G4: corrected.H6: corrected investigation clinical codes.

• Brand Name: EQ REV GLENOID PLATE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20403005
• Report Number: 1038671-2024-03874
• Device Sequence Number: 3379213
• Product Code: PHX
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/02/2025

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: 320-15-01
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 03/09/2020
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: Black Or African American