MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-06-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Equinoxe reverse 38mm humeral const liner +2.5 (cat# 320-38-13 / serial# (b)(6)).
Event or Problem Description
As reported, approximately three years post initial left tsa, the 67 male y/o patient had a single stage revision for infection.Patient was revised to exactech devices.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
A review of the sterile certificates and/or the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.D1: corrected d4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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 ; 3523771140
• MDR Report Key: 19369608
• Report Number: 1038671-2024-01266
• Device Sequence Number: 7678116
• Product Code: PHX
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-06-38
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 10/05/2020
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male