MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM HUM LINER +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	322-40-00
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-30-06 - equinoxe preserve stem 6mm, (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), 320-31-40 - glenosphere, 40mm, (b)(6), 320-35-01 - small glenoid plate, (b)(6), 321-52-07 - 3.2mm drill bit sterile, (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip, (b)(6), 322-10-00 - humeral adapter tray, +0.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a female patient, initial right shoulder implanted in (b)(6) 2024, underwent a revision procedure.Date unknown.The surgeon revised the patient¿s reverse shoulder due to instability.He removed a 40+0 liner and replaced it with a 40+2.5 constrained liner.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.X-rays were unable to be obtained.The explanted device is not available for return as the hospital kept the device.No device images were obtained.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h6.Mdr section codes updated/corrected: b, c, e.The cause of the patient¿s shoulder instability and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Instability is a known risk, as outlined in the ifu.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 40MM HUM LINER +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21539622
• Report Number: 1038671-2025-01463
• Device Sequence Number: 7736025
• Product Code: PHX
• UDI-Device Identifier: 10885862593887
• UDI-Public: 10885862593887
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/03/2025

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 Catalogue Number: 322-40-00
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2024
• 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: Required Intervention
• Patient Sex: Female