MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-40-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: 7000028 320-10-00 - equinoxe reverse tray adapter plate tray +0 7061511 320-31-40 - glenosphere, 40mm 6885686 300-30-08 - equinoxe preserve stem 8mm 7110513 315-35-00 - glnd kwire 7117585 320-15-05 - eq rev locking screw 7062567 320-20-00 - eq reverse torque defining screw kit s281361 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm s110565 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm s294817 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm s297040 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm 6977883 320-35-08 - small superior/posterior augglenoid plate,right 7110513 315-35-00 - glnd kwire 7110513 315-35-00 - glnd kwire.
Event or Problem Description
As reported, approximately 2 years and 11 months post initial right total knee arthroplasty (tka), the patient was trying to start his chainsaw and the polyethylene disassociated from the humeral tray.It was noted that the patient was regularly doing manual intensive labor.The patient underwent revision at which time the surgeon removed the glenosphere liner and humeral tray and they were replaced with a 40mm +4 glenosphere and a 0+ humeral tray, and 2.5+mm, 40mm polyethylene.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected/ additional information.The following sections were corrected/added: b2, h6: type of investigation, investigation findings and investigation conclusions.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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 40MM 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 ; 3523771140
• MDR Report Key: 20668775
• Report Number: 1038671-2024-04368
• Device Sequence Number: 15279999
• Product Code: KWT
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 07/05/2026
• Device Catalogue Number: 320-40-03
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 07/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 83 KG