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

Catalog Number	320-35-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year(s), 6 month(s) and 11 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening in which two inferior screws were reportedly broken leading to glenoid loosening.The patient underwent a standard reverse with preserve stem revision, with the reported removal of the 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 case report form indicates that this event is definitely not related to the device and/or 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
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.(d10) concomitant devices: 320-32-36 - expanded glenosphere, 36mm, for small reverse: (b)(6).300-30-06 - equinoxe preserve stem 6mm: (b)(6).320-36-00 - 145-deg pe 36mm hum liner +0: (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6).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 compression screw fracture leading to aseptic glenoid loosening as reported.However, the sequence of events, contributing factors, and reported failures cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.

• Brand Name: SMALL SUPERIOR AUGMENT 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20848827
• Report Number: 1038671-2024-04627
• Device Sequence Number: 7984642
• Product Code: KWT
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 320-35-02
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 11/03/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White