MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-24-23
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 300-30-06 - equinoxe preserve stem 6mm, (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta), (b)(6) 314-24-23 - laser cage glenoid m, 8 post aug, left, (b)(6), 531-78-20 - shouldr gps hex pins kit, 07025323058 (b)(6), - gps implant kit v2.
Event or Problem Description
It was reported that a male patient, initial left shoulder implanted on (b)(6) 2024, was converted to a reverse on an unknown date.The patient¿s shoulder was very stiff.Following the patient¿s index surgery, he developed some deltoid atrophy and showed some suprascapular and axillary nerve atrophy on emg.The surgeon decided to convert to reverse.The event happened sometime towards the end of the year.The head, replicator plate, and torque screw were removed.The stem was well fixed and retained.The laser cage glenoid was loose and able to be pulled out with a rongeur.A posterior baseplate, 2 34mm screws, 1 30mm screw, 38mm expanded sphere, locking screw, 38mm 0mm liner, 0mm tray, and reverse torque screw were implanted.Cultures were taken.There were no device breakages during the procedure.There was less than a 45-minute delay during the procedure, with no adverse event to the patient.The delay was in reference to the need for a revision surgery at all.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted product is available for return.Images were provided.No further information.

• Brand Name: EQUINOXE
• 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 66 court; gainseville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21151933
• Report Number: 1038671-2025-00250
• Device Sequence Number: 18416255
• Product Code: KWS
• UDI-Device Identifier: 10885862585356
• UDI-Public: 10885862585356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2025

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: 314-24-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male