MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	322-40-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-15-05 - eq rev locking screw (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm (b)(6) 320-31-40 - glenosphere, 40mm (b)(6) 320-35-02 - small superior augment glenoid plate (b)(6) 322-10-00 - humeral adapter tray, +0 (b)(6) a10012 - gps implant kit v2 (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
As reported by the equinoxe shoulder study, during an initial right reverse total shoulder arthroplasty, a small calcar split occurred while impacting the humeral component.The proximal humerus was cerclaged x2 with 2 nice loops of #5 ethibond.The outcome is considered to be resolved.

• Brand Name: 145-DEG PE 40MM HUM LINER +0
• 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 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24616094
• Report Number: 1038671-2026-00280
• Device Sequence Number: 18535615
• Product Code: KWT
• UDI-Device Identifier: 10885862593870
• UDI-Public: 10885862593870
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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 Expiration Date: 01/15/2026
• Device Catalogue Number: 322-40-00
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/17/2026
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White