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

Catalog Number	320-15-05
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 15 months after a left total shoulder replacement procedure, the patient underwent a revision procedure to address glenosphere loosening.The surgeon first removed the poly and the humeral plate to gain better exposure to the glenoid.He then removed the glenosphere, which was loose.The patient revised to exactech devices.No further issues or complications were reported.Patient was last known to be in stable condition following the event.Images of the x-rays were provided.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) - 320-06-38 - glenosphere 38mm.(b)(6) - 300-30-10 - equinoxe preserve stem 10mm.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-15-01 - eq rev glenoid plate.(b)(4) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) - 320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6) - 321-52-07 - 3.2mm drill bit sterile.(b)(6) - 321-52-10 - 3.2mm k-wire, thd, short 2 k-wires per pack.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03237.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely due to device-device loosening of the glenosphere locking screw and glenoid baseplate.Potential contributions of user and patient-related considerations to the event could not be assessed as the glenoid baseplate and locking screw were not returned, and radiographs closer to the revision date were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQ REV LOCKING SCREW
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22687722
• Report Number: 1038671-2025-02658
• Device Sequence Number: 9000317
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/07/2025

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: 320-15-05
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/07/2025
• Date Device Manufactured: 02/22/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male