MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM CONST HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	322-38-10
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 80 yo female patient who had an initial right shoulder implanted, underwent a revision procedure approximately 9 months post the initial procedure.The patient presented with pain.They had an infection.An antibiotic spacer and beads were inserted.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return due to chain of command.Device image was provided.No further information.
Additional Manufacturer Narrative
The revision reported was likely the result of pain and infection as reported.The humeral liner also appears to be worn.However, the reported infection cannot be confirmed and potential contributions of user-related considerations to the event could not be assessed as the devices were not returned for evaluation and relevant product images 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: 145-DEG PE 38MM CONST 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: 23052969
• Report Number: 1038671-2025-02919
• Device Sequence Number: 9320995
• Product Code: PHX
• UDI-Device Identifier: 10885862593863
• UDI-Public: 10885862593863
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: 322-38-10
• 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: 08/27/2025
• Initial Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female