MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-30-12 - equinoxe preserve stem 12mm (b)(6), 320-06-42 - glenosphere 42mm (b)(6), 320-10-15 - humeral tray +15mm (b)(6), 320-15-01 - eq rev glenoid plate (b)(6), 320-15-05 - eq rev locking screw (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6), 321-52-07 - 3.2mm drill bit sterile (b)(6).A review of complaint history determined that no further action is required as no trends were identified.No manufacturing process-related non-conformances, deviations, or exceptions are associated with the humeral stem, humeral tray, or torque defining screw packaging or manufacturing lots.No device was returned for evaluation; the reported event was confirmed by review of photographs of the device and radiograph images.The review identified that the humeral tray construct has disassembled from the humeral stem.The glenosphere does not appear to be fully seated on the glenosphere baseplate.The humeral liner appears to have wear on the edges.The humeral adapter tray appears unremarkable for an explanted device.The torque defining screw appears intact but covered in debris or soft tissue.The revision reported was likely the result of disassembly of the torque defining screw from the humeral stem and subsequent disassociation of the humeral tray construct.The observed humeral liner prosthesis wear could be due to abnormal articulation of the liner following the screw disassembly.Additionally, it is unclear whether the humeral liner nonconformance issue may have contributed to the extent of the observed edge wear.The order of events cannot be confirmed because the devices were not returned for evaluation.Potential contributions of user or patient-related considerations to the event could not be assessed.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that an 80 yo male patient, who had an initial right tsa, underwent a revision procedure, approximately 8 months post the initial procedure.The patient complained of pain.The implant disassociated.The liner was replaced.There were no surgical delays or device breakages reported.Patient was last known to be in stable condition following the event.Product is not being returned due to the hospital is unable to release without patient approval.No further information.This is 1 of 2 reports for this event.

• Brand Name: 145-DEG PE 42MM HUM LINER +0
• 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, FL 32653 ; 3525541928
• MDR Report Key: 23812531
• Report Number: 1038671-2025-03552
• Device Sequence Number: 10006793
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/15/2025

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: 320-42-00
• 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: 12/11/2025
• Initial Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 08/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male