MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	308-01-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 13a2101 - cemex system fast genta 70g: (b)(6) 308-05-23 - distal fixation ring ha 23.5: (b)(6) 308-09-00 - small prox body +0: (b)(6).308-15-01 - taper locking screw 0: (b)(6) 320-10-00 - eq rev 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) 320-31-40 - glenosphere, 40mm: (b)(6) 320-40-00 - 145-deg pe 40mm hum liner +0: (b)(6) 321-52-07 - 3.2mm drill bit sterile: (b)(6) tpa-13 - cement restrictor xs (extra small, sz 13): (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, who had a right rtsa, underwent a revision procedure.The hrp become loose and painful to patient.The humeral implants were removed and revised to a larger/longer hrp.There were no markers that would indicate infection, but the entire cement mantle also came out still attached to humeral stem.There were no device breakages or surgical delays during the procedure.X-rays were provided.The explanted devices are not available for return as they were disposed of by the hospital.Images were provided.No further information.

• Brand Name: EQUINOXE
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24944552
• Report Number: 1038671-2026-00485
• Device Sequence Number: 10084571
• Product Code: HSD
• UDI-Device Identifier: 10885862267900
• UDI-Public: 10885862267900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 04/21/2026

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: 308-01-09
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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; Required Intervention
• Patient Sex: Female