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 Code	Insufficient Information (4580)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 300-30-06 - equinoxe preserve stem 6mm, (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-15-06 - rs glenoid plate ext cag +10mm cage peg, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2025-02803.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.
Event or Problem Description
It was reported approximately five (5) years after a left reverse total shoulder replacement surgery, a patient underwent a revision procedure of the humeral tray, liner and humeral stem.X-rays and images were provided.Observations of the tray and liner noted the torque screw was intact between the liner and the tray but there was no screw threads left.There was no screw observed on x ray, and no metallosis observed.It was reported the surgeon could not find the threaded part of the break off screw anywhere in the stem or the patient.The humeral liner was noted to have minimal wear.There were no surgical delays or prolongation.No medical or surgical interventions were reported.The patient was last known to be in stable condition following the event.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d.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.The observed humeral liner prosthesis wear could be due to abnormal articulation of the liner following the screw disassembly.However, the reported wear of the humeral stem could not be confirmed as no images of the stem were provided and 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.

• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22854603
• Report Number: 1038671-2025-02804
• Device Sequence Number: 4488357
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2024
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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): Yes
• 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: 72 YR
• Patient Sex: Male