MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta).(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s.(b)(6), 315-35-00 - glnd kwire.(b)(6), 315-35-00 - glnd kwire.(b)(6), 300-20-02 - equinox square torque define screw drive kit.The reason for the revision reported cannot be confirmed from the information provided but may have been due to an insufficient bond between the glenoid component and the bone and/or the humeral stem and the bone which led to aseptic (non-infected) anatomic glenoid loosening and/or humeral loosening respectively.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
It was reported that approximately 82 months after a total shoulder replacement procedure, the patient underwent a revision procedure to address loosening.Both the humeral stem and anatomic cage glenoid components were loose.The components were easily removed and the surgeon reimplanted with competitor implants.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.No further issues or complications were reported.Photos and radiographs provided.No additional information is available.

• Brand Name: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 21881676
• Report Number: 1038671-2025-01868
• Device Sequence Number: 8741980
• Product Code: HSD
• UDI-Device Identifier: 10885862283016
• UDI-Public: 10885862283016
• Combination Product (Y/N): N
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 300-01-12
• 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: 04/11/2024
• Initial Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 04/05/2017
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male