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 Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse shoulder replacement on the right side.Subsequently, the patient noticed the shoulder felt different in the past month.It is unknown if the patient experienced an injury or fall prior.Imaging revealed the humeral liner had dissociated and was no longer sitting in the tray.The shoulder was still reduced, with the tray articulating with the glenosphere.It is unknown how long the humeral liner had been dissociated.As a result, approximately 5 years and 6 months post-surgery, the patient underwent a revision.The humeral stem was found to be well fixed and was retained.The humeral liner had migrated posterior to the glenosphere, as discovered following removal of the glenosphere.The area was extensively debrided and irrigated with antimicrobial wound solution and saline.Tissue cultures were taken due to observation of metallosis, there was no evidence of infection.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.This is report 2 of 3 for this event/patient.
Additional Manufacturer Narrative
D10: (b)(6); 320-10-00 equinoxe reverse tray adapter plate tray +0, (b)(6); 300-30-09 - equinoxe preserve stem 9mm, (b)(6); 315-35-00 - glnd kwire, (b)(6); 320-02-42 - rs expanded glenosphere 42mm, +4mm offset, (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); 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6); 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6); 321-20-00 - equinoxe reverse shoulder drill kit.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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
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: a, b, c, d, g.The revision reported was likely the result of disassembly between the humeral liner and humeral tray leading to subsequent metal-on-metal articulation between unintended components.The reported ¿metallosis¿ that was observed cannot be confirmed based on the provided information.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 disassembly of the humeral liner cannot be confirmed from the reported information.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: 22169288
• Report Number: 1038671-2025-02254
• Device Sequence Number: 21134566
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/29/2025

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: 06/25/2024
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 07/01/2019
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 140 KG