MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-15
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 315-35-00 - glnd kwire (b)(6) 315-35-00 - glnd kwire (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 320-10-05 - equinoxe reverse tray adapter plate tray +5 (b)(6) 320-15-01 - eq rev glenoid plate (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) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6) 320-38-03 - equinoxe reverse 38mm humeral liner +2.5 (b)(6) 321-52-07 - 3.2mm drill bit sterile.
Event or Problem Description
It was reported that a 63 yo male patient, initial right shoulder implanted in (b)(6) 2024, underwent a revision procedure in (b)(6) 2024, approximately 9 months post the initial procedure.The patient had reported pain.The surgeon suspected that the humerus stem had come loose.After opening and exploring, it was found that the stem had come loose.The surgeon cemented in a new 15mm stem with the same implants.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return as they were discarded at the hospital.No device images were provided.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: h3: device not returned.The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the humeral stem.However, this cannot be confirmed and potential contributions from user or patient related considerations to the event could not be assessed as the component was not returned for evaluation, and no images, radiographs, or relevant clinical information was 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
The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the humeral stem.However, this cannot be confirmed and potential contributions from user or patient related considerations to the event could not be assessed as the component was not returned for evaluation, and no images, radiographs, or relevant clinical information was provided.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 STEM PRIMARY, PRESS FIT 15MM
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 20571982
• Report Number: 1038671-2024-04194
• Device Sequence Number: 20971266
• Product Code: KWS
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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: 300-01-15
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 01/10/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/14/2025; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• 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 Age: 63 YR
• Patient Sex: Male