MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 145-DEG PE 46MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-00
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 1 year(s), 10 month(s) and 1 day(s) post-operative of a revised left tsa, it was reported via clinical study that the patient experienced unexplained pain.Patient presented with pain after working long shift, previous fall from tree - date unknown.Previous revision information was not available at this time.The patient underwent another standard reverse revision, and the outcome of this event is considered resolved.The clinical report indicates that this event is definitely not related to the device(s) and/or to the procedure.As there is no written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution, this device issue is not considered a complaint.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-14 - equinoxe humeral stem primary press fit 14mm: (b)(6); 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6); 320-02-46 - 46x21mm glenosphere high moment arm: (b)(6); 320-15-01 - eq rev glenoid plate: (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported may have been due to disassembly of the humeral liner, and/or fracture of the compression screws.However, the reported disassembly and fracture could not be confirmed.Additionally potential contributions of 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 were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE 145-DEG PE 46MM HUM LINER +0
• 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: 20587215
• Report Number: 1038671-2024-04205
• Device Sequence Number: 8796897
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 06/24/2025
• Device Catalogue Number: 320-46-00
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 06/26/2020
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White