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

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-46-00 - 145-deg pe 46mm hum liner +0: (b)(6), 300-01-14 - equinoxe humeral stem primary press fit 14mm: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6), 320-02-46 - 46x21mm glenosphere high moment arm: (b)(6).H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2024-04206.The revision reported may have been due to glenoid loosening and/or infection.However, the reported glenoid loosening and infection could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.
Event or Problem Description
It was reported during a clinical study that approximately 24 months after a revised left reverse total shoulder procedure, a patient experienced unspecified deep infection.The glenoid baseplate, screws, glenosphere and adapter tray were explanted.The patient was revised to a hemi construct due to glenoid loosening.The outcome of this event is considered resolved and the clinical report indicates that the event is definitely not related to the device(s) and/or to the procedure.This event was reported through clinical trial study data collection activities, and no other information is available at this time.

• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22328362
• Report Number: 1038671-2025-02375
• Device Sequence Number: 9483479
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: KWT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 320-15-01
• 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: 06/18/2025
• Initial Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 07/06/2020
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White