MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteolysis (2377); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: concomitants: 300-01-11 equinoxe, humeral stem primary, press fit 11mm.320-38-00 equinoxe reverse 38mm humeral liner +0.320-10-00 equinoxe reverse tray adapter plate tray +0.320-01-38 equinoxe reverse 38mm glenosphere.
Event or Problem Description
It was reported via clinical study, that the 73 yo female patient was experiencing aseptic glenoid loosening resulting in glenoid fracture or osteolysis.The date of event onset it (b)(6) 2023.The patient¿s standard reverse shoulder system was revised to hemiarthroplasty.The outcome was last known as resolved on (b)(6) 2023.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of loosening secondary to poor bone quality and fracture of the bone supporting the glenoid-side implant two months after the index procedure.However, this cannot be confirmed as the devices were not available for evaluation and no additional clinical information was provided.After further review the following has been corrected.H3: device was not returned or evaluated.

• Brand Name: EQUINOXE REVERSE GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16762320
• Report Number: 1038671-2023-00719
• Device Sequence Number: 6181943
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 06/12/2026
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 08/31/2023; 06/02/2026
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 187 LB