MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6), 320-20-00 - eq reverse torque, (b)(6), 320-01-38 - equinoxe reverse 38mm.
Event or Problem Description
It was reported that this female patient's left shoulder was revised.Patient had loosening of the humeral implants after 6 years.Patient revised to exactech devices.Surgeon put a long stem and kept the glenoid plate.
Additional Manufacturer Narrative
H3: the revision reported was most likely the result of aseptic loosening of the humeral stem after 6 years of implantation as reported.However, this cannot be confirmed and possible contributions from user or patient-related conditions to the loosening cannot be determined due to limited clinical information.Abrasive wear was noted on the inferior edge of humeral liner appears consistent with impingement between the humeral liner and native glenoid bone but is unlikely to have been the reason for revision.Neither the returned humeral tray or other returned implants appear to have any indication of breakage as initially reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: b3: occurrence date unknown.Entered erroneously in the initial report: g3: 19-jun-2024.The revision reported was most likely the result of aseptic loosening of the humeral stem after 6 years of implantation as reported.However, this cannot be confirmed and possible contributions from user or patient-related conditions to the loosening cannot be determined due to limited clinical information.Abrasive wear was noted on the inferior edge of humeral liner appears consistent with impingement between the humeral liner and native glenoid bone but is unlikely to have been the reason for revision.Neither the returned humeral tray or other returned implants appear to have any indication of breakage as initially reported.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 9MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20086753
• Report Number: 1038671-2024-03140
• Device Sequence Number: 7580815
• Product Code: KWT
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/26/2025

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: 300-01-09
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 11/05/2024; 03/25/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 12/03/2024; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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: Required Intervention
• Patient Sex: Female