MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-42-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): serial #: (b)(4), category #: 320-10-05 - equinoxe reverse tray adapter plate tray +5.Serial #: (b)(4), category #: 320-08-42 - glenosphere exp 42mm +4mm offset.Serial #: (b)(4), category #: 320-15-05 - eq rev locking screw.Serial #: (b)(4), category #: 320-20-00 - eq reverse torque defining screw kit.
Event or Problem Description
As reported, approximately 10 months post op the initial left tsa, this 64 y/o male patient was revised due to the humeral poly dissociating from humeral tray.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.
Additional Manufacturer Narrative
The revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, d8, g1, h6: annex a, d, e, f, g.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 10 months post op the initial left tsa, this patient was revised due to the humeral poly dissociating from humeral tray.Patient was last known to be in stable condition following the event.No.

• Brand Name: 145-DEG PE 42MM CONST 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 ct; gaiensville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16379051
• Report Number: 1038671-2023-00173
• Device Sequence Number: 6327491
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 02/18/2026

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: 10/01/2022
• Device Catalogue Number: 320-42-13
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 01/31/2026
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 08/10/2023; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male