MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL LINER, 40MM, +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL LINER, 40MM, +0
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6749575 320-15-05 - eq rev locking screw.7065825 320-15-05 - eq rev locking screw.7144771 320-32-40 - expanded glenosphere, 40mm, for small reverse.7290225 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
It was reported that a 73 yo female patient, initial right shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2024, approximately 1 year 10 months post the initial procedure.Upon the revision, poly wear was noticed.The patient had a competitor¿s antibiotic spacer placed due to infection.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The explanted device is not available for analysis.It was sent to pathology at the facility.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6b, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of infection as reported.The prosthesis wear noted on the lip of the humeral liner may have been subsequent to scapular notching and impingement.However, the reported infection and sequence of events could not be confirmed from the information provided.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: HUMERAL LINER, 40MM, +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 66 court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19074231
• Report Number: 1038671-2024-00768
• Device Sequence Number: 6826155
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/18/2025

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 Model Number: HUMERAL LINER, 40MM, +0
• Device Catalogue Number: 320-40-00
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 11/11/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female