MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	36MM HUMERAL LINER +0 UNCONSTRAINED
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: a101117, 308-01-09 - 9x80mm distal stem modular cemented.6577441, 308-05-22 - distal fixation ring ha 22.5.7117065, 308-08-00 - xs prox body +0.A111536, 308-15-01 - taper locking screw 0.A369316, 320-10-00 - equinoxe reverse tray adapter plate tray +0.A369830, 320-15-05 - eq rev locking screw.A367023, 320-20-00 - eq reverse torque defining screw kit.S407866, 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.A209792, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S383999, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.S384027, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.A295953, 320-31-36 - glenosphere, 36mm.6149570, 320-35-07 - small superior/posterior aug glenoid plate,left.A368531, 531-78-20 - shouldr gps hex pins kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 70 yo female patient, initial left shoulder implanted on (b)(6) 2023, underwent a revision procedure on (b)(6) 2023.The patient dislocated reaching down for something.The poly was replaced.There were no surgical delays.The patient was last known to be in stable condition following the event.No device returns anticipated due to hospital policy.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, h6 medical device problem code, component code, type of investigation and investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16668662
• Report Number: 1038671-2023-00574
• Device Sequence Number: 20463423
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/20/2025

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 Model Number: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Device Catalogue Number: 320-36-00
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 11/19/2025
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 10/09/2023; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female