MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	322-42-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-30-14 - equinoxe preserve stem 14mm.(b)(6) 320-08-42 - glenosphere exp 42mm +4mm offset.(b)(6) 320-15-01 - eq rev glenoid plate.(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) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.The revision reported was likely the result of compression screw fracture and infection.The cause of the compression screw fracture cannot be conclusively determined but may be related to improper seating of the baseplate, insufficient bone quality, insufficient number of compressions crews, and/or the reported ¿fall.¿ a secondary finding of prosthesis wear of the humeral liner was likely due to unintended impingement of the humeral liner against native glenoid bone.However, the series of events cannot be confirmed 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.
Event or Problem Description
It was reported a patient underwent a left total shoulder arthroplasty.Subsequently, one (1) year and 3(three) months later, the patient experienced pain, a fall, and was diagnosed with an infection.As a result, the patient underwent a surgery where all implants were explanted and a spacer was used.The patient was last known to be in stable condition following the event.No further patient impact was reported.No additional information is available.

• Brand Name: 145-DEG PE 42MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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
• MDR Report Key: 24071093
• Report Number: 1038671-2026-00047
• Device Sequence Number: 18486884
• Product Code: PHX
• UDI-Device Identifier: 10885862593917
• UDI-Public: 10885862593917
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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 Catalogue Number: 322-42-00
• 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: 12/31/2025
• Initial Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 03/26/2024
• 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: 84 YR
• Patient Sex: Male