MAUDE Adverse Event Report: EXACTECH, INC. SMALL GLENOID PLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Aseptic loosening (4883)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-36-03 - 36mm humeral liner +2.5mm unconstrained : 7031167.320-36-03 - 145-deg pe 36mm hum liner +2.5 : 7049043.320-31-36 - glenosphere, 36mm : 7091874.300-30-06 - equinoxe preserve stem 6mm : 6741380.320-10-00 - equinoxe reverse tray adapter plate tray +0 : 7066306.315-35-00 - glnd kwire : 7015677.320-15-05 - eq rev locking screw : 7096590.320-20-00 - eq reverse torque defining screw kit : 7005798.320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm : s297627.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm : s279420.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s243691.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm : s276888.(h3) pending evaluation.
Event or Problem Description
As reported by the equinoxe shoulder study, the 70-year-old white female had a right tsa on (b)(6) 2021.On (b)(6) 2023, the patient experience aseptic glenoid loosening.Fell postop and started to develop pain over time with glenoid/humeral loosening present on (b)(6) 2023 xr; no bacteria growth so likely aseptic loosening.The patient underwent the action of standard reverse w-preserve stem revision surgery on (b)(6) 2024.The patient was revised to non-exactech spacer and the outcome of this event is considered to be resolved.The case report form indicates that this event is possibly related to the device and definitely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6.Mdr section codes updated/corrected: b, c, d, e, g.The pain and subsequent revision reported may be due to aseptic glenoid and humeral loosening resulting from a fall as reported.However, these failures cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL GLENOID PLATE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19093927
• Report Number: 1038671-2024-00810
• Device Sequence Number: 7268747
• Product Code: PHX
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-35-01
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/16/2025; 05/16/2025
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/19/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: White