MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-30-14 - equinoxe preserve stem 14mm.(b)(6) 320-06-38 - glenosphere 38mm.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-38-03 - 145-deg pe 38mm hum liner +2.5.(b)(6) 531-55-88 - ergo gps 3.2mm drill kit sterile.(b)(6) 531-78-20 - shouldr gps hex pins kit.1032423085 a10012 - gps implant kit v2.
Event or Problem Description
It was reported that a 59 yo male patient, initial right shoulder implanted in (b)(6) 2023, underwent a revision procedure in (b)(6) 2024, approximately 1 year 3 months post the initial procedure due to disassociated humeral poly.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The device is not available for return due to hospital policy.No device images were provided.No further information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and 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 reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs 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: 145-DEG PE 38MM 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 20403962
• Report Number: 1038671-2024-03882
• Device Sequence Number: 14347511
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/11/2025

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 Catalogue Number: 320-38-03
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male