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

Catalog Number	314-13-02
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	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the 60-year-old white female had a left tsa on (b)(6) 2021.The patient present with pain on (b)(6) 2024.The patient experienced worsening pain over several months without inciting event, images demonstrated glenoid loosening.The patient is undergoing continued observation, activity modification, and consideration of revision surgery.The outcome of this event is considered continuing.The case report form indicates that this event is possibly related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-10-45 - equinoxe replicator plate 4.5mm o/s : 6725640.300-20-02 - equinox square torque define screw drive kit : 6811563.300-30-08 - equinoxe preserve stem 8mm : 6885708.310-01-44 - equinoxe, humeral head short, 44mm (alpha) : 6744700.(h3) pending evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections a2, b5, d6b, d10, g1, g3, g6, h1, h2, and h6 have been updated accordingly.(d10) concomitant device(s): 300-10-45 - equinoxe replicator plate 4.5mm o/s: (b)(6).300-20-02 - equinox square torque define screw drive kit: (b)(6).300-30-08 - equinoxe preserve stem 8mm: 6885708 310-01-44 - equinoxe, humeral head short, 44mm (alpha): (b)(6).
Event or Problem Description
Approximately 2 year(s), 7 month(s) and 14 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening the patient experienced worsening pain over several months without inciting event, images demonstrated glenoid loosening.Updated information was received, and the patient has since underwent a standard total with preserve step revision with the reported removal of the replicator plate, torque screw, humeral head, and the glenoid.The outcome of this event is now considered resolved and the clinical report indicates that this event is possibly related to the device(s) and definitely related to the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Mdr section codes updated/corrected: b, c, d, g.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 manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not 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 SMALL, ALPHA
• 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: matt collins ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19163633
• Report Number: 1038671-2024-00945
• Device Sequence Number: 7937957
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2025

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: 06/22/2022
• Device Catalogue Number: 314-13-02
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 02/14/2025
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 10/14/2024; 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• 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.; SEE H11.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White