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

Model Number	EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the 83 y/o male patient was complaining of a sore shoulder.The surgeon was revising the glenoid due to some loosening.Patient's glenoid was revised to competitor's device.There was no breakage of a device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos and x-rays received.The device is not available for evaluation due to resident wanted to keep them.
Additional Manufacturer Narrative
Corrected fields: d4, d6a, d10.Updated fields: g contact, h6: component code and investigation component code.D10: 300-30-06 - equinoxe preserve stem 6mm (b)(6).320-06-42 - glenosphere 42mm (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm (b)(6).320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6).320-42-00 - 145-deg pe 42mm hum liner +0 (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision was most likely due to fracture of the compression screws from increased bending moments caused by baseplate loosening and/or an inadequate number of screws being used for fixation.Furthermore, the prothesis wear on the humeral liner from scapular notching and/or the inclusion of the polyethylene in the packaging recall could have contributed to the reason for revision.However, the cause for the wear and fracture can not be confirmed from the provided information.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 66th ct; gainesville, FL 32653
• MDR Report Key: 19167245
• Report Number: 1038671-2024-00954
• Device Sequence Number: 7855649
• 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: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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 Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: Not provided; 03/31/2025
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 12/12/2024; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male