MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: rs expanded glenosphere 42mm +4 320-02-42 (b)(6).Eq rev adapter plate tray +0 320-10-00 (b)(6).Eq rev locking screw 320-15-05 (b)(6).Eq rev torque screw kit 320-20-00 (b)(6).Eq rev compr screw 26mm 320-20-26 (b)(6).Eq rev compr screw 30mm 320-20-30 (b)(6).Eq rev compr screw 38mm 320-20-38 (b)(6).Eq rev 42mm humeral liner +0 320-42-00 (b)(6).The revision reported may be the result of the glenoid and humeral component loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 5 years and 8 months post the initial left total shoulder arthroplasty, the patient was revised due to component loosening.There was severe bone loss.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• 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: 22175101
• Report Number: 1038671-2025-02263
• Device Sequence Number: 18097401
• Product Code: PHX
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 300-30-08
• 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: 12/03/2024
• Initial Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 08/24/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male