MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL LINER, 40MM, +0; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	HUMERAL LINER, 40MM, +0
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study, ¿equinoxe shoulder study¿, that a 55 yo female patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient dislocated their left shoulder anteriorly/inferiorly on (b)(6) 2023, with no injury reported, and underwent revision due to an acute inferior dislocation.The humeral liner was revised.The study indicates the event was definitely not related to the device or the procedure.The event was resolved on (b)(6) 2023.No further details.
Additional Manufacturer Narrative
D10: concomitants:5.6969622 300-01-07 - equinoxe, humeral stem primary, press fit 7mm.A280070 320-31-40 - glenosphere, 40mm.A314350 320-10-00 - equinoxe reverse tray adapter plate tray +0.A316194 320-35-01 - small glenoid plate.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.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.The reason for the reported revision due to dislocation cannot be conclusively determined; however, it may be due to soft tissue imbalance, rotator cuff failure, patient anatomy, implant positioning, and/or implant selection.Dislocation 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: EQUINOXE HUMERAL LINER, 40MM, +0
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18692367
• Report Number: 1038671-2023-02618
• Device Sequence Number: 7071125
• Product Code: KWS
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Model Number: HUMERAL LINER, 40MM, +0
• Device Catalogue Number: 320-40-00
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White