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

Catalog Number	320-55-98
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had a left rtsa, underwent a revision procedure.Following the surgery all was well with the patient.Almost a month after the initial surgery, she reached back to put the legs up on her recliner and felt a pop.X-rays confirmed the glenosphere had moved and wasn't fully seated.The loose glenosphere was removed along with the locking plate, csb glenosphere locking screw and liner.We then revised with a new 36 glenosphere, csb glenosphere screw, locking plate/ring and 36 liner.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not able to be returned.The hospital does not allow removal.Device images were provided.No further information.This is 1 of 2 reports.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 court; gainseville, FL 32653 ; 3523771140
• MDR Report Key: 25352853
• Report Number: 1038671-2026-00688
• Device Sequence Number: 10444723
• Product Code: KWT
• UDI-Device Identifier: 10885862630384
• UDI-Public: 10885862630384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/01/2026

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: 320-55-98
• 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: 05/10/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2025
• 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; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female