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	Pain (1994); Aseptic loosening (4883)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year(s), 7 month(s) and 8 day(s) post-operative of a revised right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening with progressively worsening pain for 3 months without inciting event.In an earlier reported event, 9 days post-operative of the initial implantation, the patient underwent a 2-stage revision for glenoid/coracoid fracture which loosened glenoid.Patient did not report injury, but glenoid component was found to have shifted at initial post-op appointment.The patient underwent resection arthroplasty with explantation of all components including the torque screw, preserve stem, humeral tray, humeral liner, glenosphere, glenosphere locking screw, glenoid base plate, and compression screw/locking cap components.The outcome of this event is considered resolved and the clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-10 - equinoxe preserve stem 10mm: (b)(6) (implanted (b)(6) 2022).320-31-36 - equnioxe glenosphere, 36mm: (b)(6).320-10-00 - reverse tray adapter plate tray +0: (b)(6).320-36-00 - 145-deg pe 36mm hum liner +0: (b)(6).320-15-05 - eq rev locking screw: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
The revision reported may be the result of the glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiographs, images, or clinical information was provided.H6: corrected health effect and investigation clinical codes.H10 related report numbers: 1038671-2024-04510 and 1038671-2024-04511.

• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21358748
• Report Number: 1038671-2025-00835
• Device Sequence Number: 8481652
• Product Code: PHX
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 01/24/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 06/21/2022
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White