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 Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, at a doctor appointment per surgeon, the male patient does a labor job (flooring), picked up a heavy object and felt a "pop'.There were fragments, parts, or pieces that felt into the patient, all the fragments, parts or pieces were remove.The patient was revised to a 38 +2.5 liner and +0 tray exactech devices.Patient was last known to be in stable condition following the event.Images and x-rays received.The devices are available for evaluation.
Additional Manufacturer Narrative
D10 - concomitants: (b)(6) - 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(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) - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(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) - 320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6) - 320-38-03 - 145-deg pe 38mm hum liner +2.5.The revision reported was likely the result of humeral tray fracture.The cause of the tray fracture cannot be conclusively determined; however, may be due to lack of bony support and poor bone quality and/or abnormal articulation following a humeral liner disassociation event.Potential scapular notching of the humeral components on native glenoid bone may have contributed to humeral liner disassembly and subsequent abnormal loading forces being applied to the humeral tray, resulting in the observed fracture.Additionally, it is unclear whether the nonconformance issue may have contributed to the extent of the observed impingement and subsequent edge wear, humeral liner disassociation, and humeral tray fracture.The series of events could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24022139
• Report Number: 1038671-2026-00026
• Device Sequence Number: 16090673
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• 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: 2021
• 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
• Report Date (Section B): 01/09/2026

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: 03/04/2026
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/09/2026
• Date Device Manufactured: 03/17/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male