MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 8X200MM DISTAL STEM MODULAR CEMENTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	308-03-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 6 year(s), 11 month(s) and 24 day(s) post-operative of a revised left rtsa, it was reported via clinical study that the patient experienced aseptic humeral loosening of the humeral stem.The patient is scheduled to undergo a standard reverse with humeral reconstruction revision including the removal of the distal stem, distal fixation ring, middle segment, proximal body, and locking screw.The outcome of this event is considered continuing until the surgery and the clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-42-00 - equinoxe reverse 42mm humeral liner +0: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere: (b)(6), 320-15-02 - rs glenoid plate sup aug, 10 deg: (b)(6), 308-05-23 - distal fixation ring ha 23.5: (b)(6), 308-09-12 - small prox body +12.5: (b)(6), 308-15-12 - taper locking screw 12.5: (b)(6).
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information was not provided.

• Brand Name: EQUINOXE 8X200MM DISTAL STEM MODULAR CEMENTED
• 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20547176
• Report Number: 1038671-2024-04139
• Device Sequence Number: 7481305
• Product Code: KWT
• UDI-Device Identifier: 10885862267993
• UDI-Public: 10885862267993
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Expiration Date: 08/27/2025
• Device Catalogue Number: 308-03-08
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 04/01/2025
• Date Device Manufactured: 09/01/2015
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White