MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-06
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845); Septic loosening (4884)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Concomitants: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm; (b)(6), 320-31-36 - glenosphere, 36mm; (b)(6), 320-35-01 - small glenoid plate; (b)(6), 320-36-00 - 145-deg pe 36mm hum liner +0.
Event or Problem Description
It was reported via clinical study that the 57 yo male patient experienced septic loosening.The date of event onset is (b)(6)2021.The patient was revised on (b)(6)2022.Previous: right arthroscopic rotator cuff repair in 2012, 2 additional arthroscopies in 2014.The patient¿s outcome was last known as resolved on (b)(6)2023.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: a, b, c, d, e, f, g.The revision reported may be the result of the humeral stem septic loosening and subsidence as reported.However, the loosening and subsidence cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.A review of the sterile certificate for all explanted components was performed and the sterile lots were accepted to the requirements should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRESERVE STEM 6MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17410964
• Report Number: 1038671-2023-01801
• Device Sequence Number: 12548757
• Product Code: KWS
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 10/15/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 300-30-06
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White