MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-15
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: the pain and subsequent revision reported cannot be confirmed from the information provided but may be the result of component loosening leading to a loss of range of motion as reported.However, the reported glenoid loosening, humeral loosening, and decreased range of motion cannot be confirmed and potential contributions of manufacturing, user, or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and relevant product information was not provided.D10: 300-10-15/45, equinoxe replicator plate unknown.Equinoxe primary torque screw unknown.310-01-47, equinoxe primary humeral head 47mmx18mm, 77082007.
Event or Problem Description
As reported, the patient has had many previous surgeries on their right shoulder, starting with scopes and then a hemi arthroplasty that was converted to an equinoxe primary total shoulder.The patient was never satisfied with their shoulder outcomes and reported pain, stiffness, and decreased motion.The patient presented to the surgeons office with these complaints.The surgeon scheduled the patient for revision primary total shoulder to a competitors reverse shoulder arthroplasty.The surgeon anticipated the implants being loose.The patient had surgery where the surgeon removed the equinoxe primary implants and glenoid anchors shown on the x-ray.He cultured and irrigated the joint/wound and reimplanted a competitors reverse tsa construct.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g3.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22480512
• Report Number: 1038671-2025-02486
• Device Sequence Number: 15589493
• Product Code: KWS
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/11/2025

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: 300-01-15
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Male