MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE EXT CAG +10MM CAGE PEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Insufficient Information (4580)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that the 43 yo male patient experienced aseptic glenoid loosening.The date of event onset is (b)(6) 2022.The patient was revised on (b)(6) 2023.The patient¿s outcome was last known as continuing.
Additional Manufacturer Narrative
Concomitant medical products: reverse glenosphere 3200242.Humeral stem or stemless 3000115.Reverse humeral liner 3204200.Reverse humeral tray 3201000.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the glenoid component and the bone interface, which led to aseptic loosening.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no images or radiographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17338554
• Report Number: 1038671-2023-01684
• Device Sequence Number: 15105247
• Product Code: KWS
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 320-15-06
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: Black Or African American