MAUDE Adverse Event Report: EXACTECH, INC. EQ REVERSE TORQUE DEFINING SCREW KIT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 9 years and 7 months post the initial right reverse total shoulder arthroplasty, the patient dislocated their shoulder and wore the humeral tray as it rubbed against the glenosphere.The surgeon removed the glenosphere and all humeral components before re-implanting another exactech prosthesis.Photos provided showed wear of the humeral liner, tray, and glenosphere.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.It was identified during investigation that the equinoxe reverse torque defining screw showed prosthesis wear.
Additional Manufacturer Narrative
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.D10: (b)(6) 320-15-01 - eq rev glenoid plate, (b)(6) 320-15-05 - eq rev locking screw, (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) 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, (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.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely due to the reported dislocation resulting in disassembly between the humeral liner and humeral tray and subsequent unintended metal-on-metal articulation and prosthesis wear of the disassociated humeral liner.However, the dislocation and series of events contributing to these failures cannot be confirmed as the devices were not returned for evaluation and no radiographs were provided for review.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21978679
• Report Number: 1038671-2025-01995
• Device Sequence Number: 7151419
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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): 10/27/2025

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: 07/09/2020
• Device Catalogue Number: 320-20-00
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 07/13/2015
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 108 KG