MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Metal Related Pathology (4530)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left reverse total shoulder arthroplasty.Subsequently, the patient experienced pain approximately 5 years and 6 months after initial implantation.Radiographs taken showed that the humeral liner and humeral tray had disassociated.As a result, the patient underwent a left shoulder revision approximately 6 years and 10 months after initial implantation.Provided images of the explanted devices show signs of wear and metal-related pathology.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
D10: (b)(6) 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-15-05 - eq rev locking screw.(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) 320-20-30 - 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) 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6) 320-10-10 - equinoxe reverse tray adapter plate tray +10.(b)(6) 320-20-00 - eq reverse torque defining screw kit.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 corrected/ additional information.The following sections were corrected/added: h6: component code, type of investigation, investigation findings and investigation conclusions.The revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent prosthesis wear of the humeral liner and metal-on-metal articulation between the humeral tray and glenosphere.The cause of the humeral liner disassembly cannot be confirmed but may be related to patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above.The series of events cannot be confirmed as the devices and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 38MM CONST HUM LINER +2.5
• 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: 23391015
• Report Number: 1038671-2025-03187
• Device Sequence Number: 15913732
• Product Code: KWT
• UDI-Device Identifier: 10885862086686
• UDI-Public: 10885862086686
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/09/2026

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 Expiration Date: 07/24/2023
• Device Catalogue Number: 320-38-13
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 07/26/2018
• 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; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male