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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Joint Impingement (4834); Bone Notching (4890)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the left side.Subsequently, the patient experienced instability and bone notching.As a result, approximately two years and three-months post-surgery, the patient underwent a revision.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.This is report 1 of 2 for this event/patient.
Additional Manufacturer Narrative
D10: 320-10-05 - equinoxe reverse tray adapter plate tray +5: sn# (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq reverse torque defining screw kit: sn# (b)(6), 320-32-40 - expanded glenosphere, 40mm, for small reverse: sn# (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of instability and prosthesis wear of the humeral liner as reported.The inferior wear observed on the explanted humeral liner likely occurred due to impingement between the liner and native glenoid bone.It remains unclear if the observed wear contributed to the reported instability.Instability and the 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 post-operative or pre-revision radiographs were not provided.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: 22698945
• Report Number: 1038671-2025-02666
• Device Sequence Number: 9010982
• Product Code: KWS
• UDI-Device Identifier: 10885862535061
• UDI-Public: 10885862535061
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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): 10/29/2025

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: 10/28/2025
• Device Catalogue Number: 320-40-13
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Date Device Manufactured: 11/02/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female