MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 46MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 42 months post the initial reverse total shoulder arthroplasty, the patient was revised due to pain.Intraoperative photos and x-rays were provided.No surgical or medical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6) 320-01-46 - equinoxe reverse 46mm glenosphere.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-15-01 - eq rev glenoid plate.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) 320-46-13 - 145-deg pe 46mm const hum liner +2.5.(b)(6) 321-52-07 - 3.2mm drill bit sterile.H10: multiple mdr reports were filed for this event, please see associated report: 1038671-2025-02187.The product associated with the reported event is within the scope of recall z-1425-2024; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.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.
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 may be the result of pain and prosthesis wear.The observed edge wear of the humeral liner was likely due to scapular notching and may have contributed to the reported pain and may have created the formations observed in the provided radiographs.However, this cannot be confirmed based on the provided information and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no relevant clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 145-DEG PE 46MM 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
• MDR Report Key: 22100643
• Report Number: 1038671-2025-02188
• Device Sequence Number: 18274327
• Product Code: KWT
• UDI-Device Identifier: 10885862086761
• UDI-Public: 10885862086761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/24/2025

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: 11/19/2022
• Device Catalogue Number: 320-46-13
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 10/24/2025
• Date Device Manufactured: 11/20/2017
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown