MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-04
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year(s), 7 month(s) and 11 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening; gradual increase in pain over last 6 months-loose stilted baseplate supported with montage.The patient underwent standard reverse revision surgery and was revised to a spacer.The outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-06-38 - glenosphere 38mm: 7308798.320-38-00 - 145-deg pe 38mm hum liner +0: s383183.300-30-10 - equinoxe preserve stem 10mm: a159595.320-10-00 - equinoxe reverse tray adapter plate tray +0: a249664.320-15-05 - eq rev locking screw: a240339.320-20-00 - eq reverse torque defining screw kit: a220238.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: a027031.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: a186841.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 7287523.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: s370014.315-35-00 - glnd kwire: 6102820.315-35-00 - glnd kwire: a185742.
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 glenoid loosening.However, the reported glenoid loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not 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 R POST AUG, 8 DEG, RIGHT
• 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 ; 3523771140
• MDR Report Key: 20047955
• Report Number: 1038671-2024-03027
• Device Sequence Number: 20823099
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• 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: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 320-15-04
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 04/08/2025
• Date Device Manufactured: 08/10/2022
• 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.
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White