MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 145-DEG PE 46MM HUM LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-03
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-01-13 - eq, humeral stem primary, press fit 13mm: 4259111 (remained implanted from index surgery on (b)(6) 2016) 320-01-46 - equinoxe rev 46mm glenosphere: 2646032 320-15-01 - eq rev glenoid plate: 4211947 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 8 year(s), 4 month(s) and 2 day(s) post-operative of a revised right rtsa, it was reported via clinical study that the patient experienced disassociation of polyethylene.Patient's shoulder 'locked up' while at work with feelings of instability thereafter.The patient underwent a tendon transfer with rotator cuff repair 3 months post operatively (see case-(b)(4) and was revised approximately 5 months post operative of the initial implantation of devices for unknown reasons.(see case-(b)(4) one month and five days following the onset of symptoms, the patient underwent a standard reverse revision with reported removal of the torque screw, humeral tray, humeral liner, glenosphere, and glenosphere locking screw components.The outcome of this event is considered resolved, and the case report form indicates that this event is possibly related to the device(s) and definitely related to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
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 was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs 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 +2.5
• 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
• MDR Report Key: 21358650
• Report Number: 1038671-2025-00832
• Device Sequence Number: 8434827
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: 03/23/2020
• Device Catalogue Number: 320-46-03
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 03/26/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White