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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-42-03 - 145-deg pe 42mm hum liner +2.5: (b)(6).300-01-13 - equinoxe, hum stem primary, press fit 13mm: (b)(6).320-06-42 - glenosphere 42mm: (b)(6).320-10-05 - equinoxe rev tray adap plate tray +5: (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).320-20-34 - eq rev compres scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev compres scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev compres scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-38 - eq rev compres scr lck cap kit, 4.5 x 38mm: (b)(6).320-42-03 - 145-deg pe 42mm hum liner +2.5: (b)(6).321-20-00 - equinoxe reverse shoulder drill kit: (b)(6).321-52-07 - 3.2mm drill bit sterile: (b)(6).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, approximately 2 years and 7 months post the initial left reverse total shoulder arthroplasty, the patient was brought back with shoulder instability.The shoulder was dislocated.Photos provided show wear of the liner.The poly liner, torque screw and humeral tray were removed.The surgeon opted to trial with a +15 setup.This was found to be well stable.A new +15 tray, torque screw and 42 +0 constrained liner were implanted.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.

• 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: 23391891
• Report Number: 1038671-2025-03195
• Device Sequence Number: 10052685
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• 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: 2022
• 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
• Report Date (Section B): 10/27/2025

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: 10/07/2025
• Initial Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 03/31/2022
• 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.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female