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	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Fall (1848)
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.
Event or Problem Description
As reported, the surgeon states the patient fell and fractured their elbow on the implant side.It was believed to be treated non-operatively, but the surgeon believed because of the fall the patient point-loaded on the poly and it dislocated from the tray.The patient was exposed and the liner was in fact dislocated and located posterior/superior of the humeral tray.There was some wear on the liner and of the tray on the inferior portion likely due to rubbing on the sphere.The glenoid components were intact and left alone.The torque screw and tray were removed with the liner, and replaced with new implants.There was no reported breakage of the 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 information.The following sections were updated: d10.D10: (b)(6) 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(b)(6) 320-06-42 - glenosphere 42mm.(b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) 320-15-04 - rs glenoid plate r post aug, 8 deg, right.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-00 - eq reverse torque defining screw kit.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 531-20-00 - shldr gps rvrs drill kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.(b)(6) a10012 - gps implant kit v2.
Additional Manufacturer Narrative
The revision reported was likely the result of disassembly between the humeral liner and the humeral tray leading to subsequent metal-on-metal articulation between components as well as damage to the disassociated liner.The humeral liner and tray disassembly was likely caused by the reported fall the patient sustained on their implant side.However, this cannot be confirmed because the components were not returned for evaluation.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 problem code.

• 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: 21429031
• Report Number: 1038671-2025-01129
• Device Sequence Number: 14540305
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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: 2023
• 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,Followup
• Report Date (Section B): 04/07/2025

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: 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: 01/31/2025
• Supplement Date Received by Manufacturer: 01/31/2025; 04/04/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 02/20/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male