MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	36MM HUMERAL LINER +0MM CONSTRAINED
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/01/2019
Type of Reportable Event	Death
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2019.The patient presented on (b)(6) 2019 and post op scapula fx.The case report form indicates that this event is possibly related to device, definitely related to procedure.
Additional Manufacturer Narrative
Pending investigation.D10: serial number: item number and full description: (b)(6), 308-05-17 - distal fixation ring ha 17.5.(b)(6), 308-02-06 - 6x120mm distal stem modular cemented.(b)(6), 308-15-12 - taper locking screw 12.5.(b)(6), 308-08-12 - xs prox body +12.5.(b)(6), 320-01-36 - 36mm glenosphere.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.

• Brand Name: EQ REV GLENOID PLATE
• 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
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17842039
• Report Number: 1038671-2023-02401
• Device Sequence Number: 11862348
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2026

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
• Device Expiration Date: 02/19/2024
• Device Model Number: 36MM HUMERAL LINER +0MM CONSTRAINED
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2023
• Supplement Date Received by Manufacturer: 07/22/2026; 07/22/2026
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 07/27/2026; 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Patient Weight: 108 LB
• Patient Race: White