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

Catalog Number	320-35-06
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	04/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op initial tsa, this 77 y/o female patient was revised due to aseptic glenoid loosening with increased pain.Surgeon revised to a hemiarthroplasty.The case report form indicates this event is possibly related to devices and unlikely related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant device(s): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.320-36-00 - 36mm humeral liner +0 unconstrained.320-11-00 - reverse humeral tray.320-35-06 - small extended cage glenoid plate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The pain and subsequent revision reported may be the result of aseptic glenoid loosening as reported.However, the failure 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.The following sections were updated/corrected: h4.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL EXTENDED CAGE 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, INC; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16987479
• Report Number: 1038671-2023-01091
• Device Sequence Number: 12455405
• Product Code: PHX
• UDI-Device Identifier: 10885862534903
• UDI-Public: 10885862534903
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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: 320-35-06
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 05/15/2025; 05/15/2025
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 05/16/2025; 05/16/2025
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White