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

Catalog Number	320-42-03
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Metal Related Pathology (4530)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years and 1 month post the initial right reverse total shoulder arthroplasty, the patient was revised due to poly wear/fracture.The liner and glenosphere were exchanged.Photos provided indicate there may be metal-on-metal wear between the glenosphere and tray.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
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: (b)(6), gps implant kit v2.(b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6), 320-15-04 - rs glenoid plate post aug, 8 deg, right.(b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6), 320-15-05 - eq rev locking screw.(b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(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), 531-20-00 - shldr gps rvrs drill kit.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6), 531-78-20 - shouldr gps hex pins kit.(b)(6), 531-78-20 - shouldr gps hex pins kit.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6.The revision reported was likely the result of the reported traumatic event and bone fracture.A secondary finding of edge wear of the humeral liner appears consistent with humeral liner disassociation and subsequent metal-on-metal articulation; however, these failure modes were reported to not have occurred.Additionally, the reported traumatic event and subsequent fracture could have been a contributing factor to the observed wear of the humeral liner.However, the traumatic event, fracture, and series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no radiographs or relevant clinical information were 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 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: 22069422
• Report Number: 1038671-2025-02116
• Device Sequence Number: 21010393
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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 Expiration Date: 03/13/2024
• Device Catalogue Number: 320-42-03
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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: 82 YR
• Patient Sex: Male