MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 320-40-03 - 145-deg pe 40mm hum liner +2.5: 7229077 320-10-00 - equinoxe reverse tray adapter plate tray +0: a412805 320-31-40 - glenosphere, 40mm: 6933692 320-35-06 - small extended cage glenoid plate: 7033890.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2023.The patient presented on (b)(6) 2023 with aseptic humeral loosening.Patient reports significant pain.X-rays show lucency around cement of the humerus, likely indicating loosening of hardware.The case report form indicates that this event is definitely related to device and/or to procedure.Outcome is continuing.No device return anticipated due to being a clinical trial study.
Additional Manufacturer Narrative
The revision reported may be the result of the humeral 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.D4: corrected h6: corrected health effect, component, and investigation clinical codes.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18419169
• Report Number: 1038671-2023-03075
• Device Sequence Number: 7965061
• Product Code: KWS
• UDI-Device Identifier: 10885862283009
• UDI-Public: 10885862283009
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 300-01-10
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White