MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-13
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6): 310-00-47 - xs humeral head, 47mm xs offset humeral head.(b)(6): 300-50-45 - 4.5mm short rep plate.(b)(6): 300-20-02 - equinox square torque define screw drive kit.(b)(6): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial right tsa on (b)(6)2014.The patient presented on (b)(6) 2023 with aseptic glenoid loosening.Initially noted glenoid loosening on (b)(6) 2021 x-ray.Had increasing pain & loosening in last year.Supraspinatus was absent at the time of revision surgery & glenoid was worn and loose.The case report form indicates that this event is unlikely related to device and definitely related to procedure.Outcome was resolved on (b)(6) 2023.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reported shoulder pain may be the result of glenoid loosening and prosthesis wear due to eccentric loading of the glenoid secondary to instability resulting from the reported rotator cuff tear.However, the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed 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 CAGE GLENOID MEDIUM, BETA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: kate jacobson ; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18280170
• Report Number: 1038671-2023-02926
• Device Sequence Number: 17619800
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 02/04/2019
• Device Catalogue Number: 314-13-13
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2014
• 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 H10
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White