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

Catalog Number	314-13-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 4 year(s) and 17 day(s) post-operative of a right tsa, the patient presented with aseptic glenoid loosening.It was reported as migration of the central peg, now resulting in complete glenoid loosening.The patient is schedule for revision to hemiarthroplasty, however the outcome of this event is still considered continuing and the device(s) remain implanted.The clinical report indicates that this event is definitely related to the device(s) and definitely not related to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm: 4889445; 300-10-15 - equinoxe replicator plate 1.5mm o/s: 4895026; 300-20-02 - equinox square torque define screw drive kit: 4848147; 310-01-44 - equinoxe, humeral head short, 44mm (alpha): 4902190; a10012 - gps implant kit v2: 05005017040.
Additional Manufacturer Narrative
After review of information received and the completion of investigation, the following sections g1, g3, g6, h1, h2, h3 and h6 have been updated accordingly.(h3): the revision reported was likely the result of an insufficient bond between the cage glenoid component and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the device was not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d6.The following sections were corrected: h6.The revision reported was likely the result of an insufficient bond between the cage glenoid component and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the device was not returned for evaluation, and images and radiographs 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 MEDIUM, 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19702748
• Report Number: 1038671-2024-02326
• Device Sequence Number: 17057267
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2025

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: 02/22/2022
• Device Catalogue Number: 314-13-03
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 01/07/2025
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 11/06/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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 H11.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 90 KG