MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-40-03 - humeral liner, 40mm, +2.5: (b)(6); 300-30-10 - equi preserve stem 10mm: (b)(6); 320-10-00 - equi revtray adapter plate tray +0: (b)(6); 320-15-05 - eq rev locking screw: (b)(6); 320-20-00 - eq rev torque defining screw kit: (b)(6); 320-20-18 - eq rev comp scr lck cap kit, 4.5 x 18mm: (b)(6); 320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6); 320-20-30 - eq rev comp scr lck cap kit, 4.5 x 30mm: (b)(6); 320-20-38 - eq rev comp scr lck cap kit, 4.5 x 38mm: (b)(6); 320-31-40 - glenosphere, 40mm for small reverse: (b)(6); 320-35-07 - small sup./post.Aug glenoid plate, left: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient who had a left total shoulder arthroplasty underwent a revision procedure 38 days post the initial procedure.During removal of the definitive humeral adaptor tray, the fixation of the preserve stem was compromised.The humerus was prepped for a standard stem.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11.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.A review of complaint history determined that no further action is required as no trends were identified.The loosening reported was likely the result of forces being applied to the humeral tray during its removal which led to the anchorage of the attached stem being compromised.However, this cannot be confirmed because the components were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23645943
• Report Number: 1038671-2025-03452
• Device Sequence Number: 11987897
• Product Code: KWT
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 03/06/2026

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 Catalogue Number: 300-30-10
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/06/2026
• Date Device Manufactured: 06/06/2024
• 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 Sex: Female