MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 6MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446); Aseptic loosening (4883)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-31-36 - glenosphere, 36mm: 6314160.320-35-02 - small superior augment glenoid plate: 6266896.320-36-00 - 36mm humeral liner +0 unconstrained: 6297100.320-10-00 - equinoxe reverse tray adapter plate tray +0: 6361337.320-15-05 - eq rev locking screw: 6361232.320-20-00 - eq reverse torque defining screw kit: 6350636.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 6185767.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 6318483.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: 6318529.321-20-00 - equinoxe reverse shoulder drill kit: 6318326.
Event or Problem Description
Approximately 2 year(s) and 14 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic humeral loosening.Patient presented with increased pain.The humeral stem was found to be loose.The patient underwent standard reverse with preserve stem revision surgery, and the outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported may be the result of the humeral loosening as reported.However, the loosening cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as the devices were not returned for evaluation and no images or radiographs were 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 PRESERVE STEM 6MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 20046458
• Report Number: 1038671-2024-03024
• Device Sequence Number: 7955183
• Product Code: PHX
• UDI-Device Identifier: 10885862515742
• UDI-Public: 10885862515742
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Catalogue Number: 300-30-06
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 08/23/2019
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: Black Or African American