MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 46MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 81 y/o male patient's left shoulder was revised approximately 4 years post op.Surgeon revised an exactech reverse shoulder due to a displaced 46 liner.He removed a 46 inset glenosphere and displaced liner and replaced with a 42+4 glenosphere and a 42, constrained, 135 degree liner with new locking mechanism.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 6599706 300-30-06 - equinoxe preserve stem 6mm.6567319 320-10-00 - equinoxe reverse tray adapter plate tray +0.6496707 320-15-01 - eq rev glenoid plate.6489612 320-15-05 - eq rev locking screw.6615980 320-20-00 - eq reverse torque defining screw kit.S086096 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S080662 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.S083587 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.6023499 320-02-46 - 46x21mm glenosphere high moment arm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11 mdr section codes updated/corrected: b, c, d, g the revision was likely the result of disassembly between the humeral liner and humeral tray leading to the humeral liner backside wear.Potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the disassembly of the humeral liner cannot be confirmed 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.

• Brand Name: 145-DEG PE 46MM HUM LINER +2.5
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20239068
• Report Number: 1038671-2024-03559
• Device Sequence Number: 8755000
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2024
• Device Catalogue Number: 320-46-03
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/23/2025
• Date Device Manufactured: 12/18/2019
• 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: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male