MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 12 months after a left total shoulder replacement procedure, the patient underwent a revision procedure to address pain and loosening.The surgeon removed a loose equinoxe glenoid baseplate and 42+4 glenosphere.He replaced them with a competitor¿s devices.There was no reported surgical delay or breakage of a device.Patient was last known to be in stable condition following the event.X-rays were unable to be obtained.The explanted devices are not available for return.They were sent to spd.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 320-15-05 - eq rev locking screw; (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm; (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) 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b, c, d, g.D6b explant date is unknown.The reason for the revision cannot be confirmed from the provided information but may be due to an insufficient bond between the glenoid baseplate and the bone leading to aseptic (non-infected) loosening.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQ REV GLENOID PLATE
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19726444
• Report Number: 1038671-2024-02364
• Device Sequence Number: 8290969
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• 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?: Yes
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 72 KG