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	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately six years post initial right tsa, the 71 y/o male patient experienced aseptic glenoid loosening, the patient may have rotator cuff tear.Patient threw piece of wood and injured right shoulder.The event still ongoing.Per clinical report, the event is not related to the device or to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-10-45 - equinoxe replicator plate 4.5mm o/s : 5033412.300-20-02 - equinox square torque define screw drive kit : 5018340.300-30-12 - equinoxe preserve stem 12mm : 5076642.300-50-45 - 4.5mm short rep plate : 5075518.310-00-50 - equinoxe, humeral head, extra short, 50mm : 4622322.(h3) pending evaluation.
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 glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville 32653 ; 3523771140
• MDR Report Key: 19356365
• Report Number: 1038671-2024-01357
• Device Sequence Number: 14395242
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 10/17/2021
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2016
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White