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

Catalog Number	322-42-13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: 304-21-13 - 12.5mm platform fx stem left: (b)(6).320-06-42 - glenosphere 42mm: (b)(6).320-15-01 - eq rev glenoid plate: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq rev torque defining scr kit: (b)(6).320-20-26 - eq rev com scr lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6).320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6).320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6).321-52-07 - 3.2mm drill bit sterile: (b)(6).
Event or Problem Description
As reported, the patient underwent an initial left reverse total shoulder arthroplasty approximately 3 months ago.The patient complained of pain and was revised due to poly disassociation.There was no reported breakage of a device or 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 additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11.Mdr section codes updated/corrected: b, c, d.The revision 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 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 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22478497
• Report Number: 1038671-2025-02483
• Device Sequence Number: 8040891
• Product Code: KWT
• UDI-Device Identifier: 10885862593948
• UDI-Public: 10885862593948
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 322-42-13
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• 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
• Patient Age: 87 YR
• Patient Sex: Male