MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 40MM CONST HUM LINER +2.5; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-40-13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 6575109 / 320-40-13 - 145-deg pe 40mm const hum liner +2.5 6889247 / 320-20-02 - right augment std 6996932 / 320-00-12 - 0 lat right tray a003014 / 300-01-12 - equinoxe humeral stem primary press fit 12mm a257914 / 320-20-00 - eq reverse torque defining screw kit multiple mdr reports were filed for this event, please see associated reports 1038671-2025-02988.Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
As reported, approximately 2 years post the initial right reverse total shoulder arthroplasty, the patient was revised due to dislocation.The patient indicated no trauma occurred.The surgeon observed the polyethylene component dissociated from the tray and flipped over.No abnormal wear was noted on the face of the polyethylene component that might affect the locking mechanism of the polyethylene liner to the tray.The surgeon reported there could have possibly been an issue with the locking mechanism of the poly.The surgeon reported it was also possible the poly wasn't impacted firmly enough on the initial surgery.The patient was revised to 40 +2.5 constrained liner.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.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h4, g4, h6 mdr section codes updated/corrected: b, c, d, g the revision reported was likely the result of dislocation and disassembly between the humeral liner and humeral tray, which led to wear on the backside of the liner.However, the dislocation cannot be confirmed based on the information provided, and it is unclear if it occurred prior to or after the humeral liner disassembly.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 40MM CONST HUM LINER +2.5
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 23148676
• Report Number: 1038671-2025-02989
• Device Sequence Number: 10612642
• Product Code: KWS
• UDI-Device Identifier: 10885862535061
• UDI-Public: 10885862535061
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/31/2025

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: 06/21/2025
• Device Catalogue Number: 320-40-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 06/23/2020
• 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; Required Intervention
• Patient Sex: Unknown