MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-34
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm: (b)(6), 300-10-15 - equinoxe replicator plate 1.5mm o/s: (b)(6), 310-01-50 - equinoxe, humeral head short, 50mm (beta): (b)(6).
Event or Problem Description
Post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.It was further stated hybrid glenoid with loosening.Peg displacement.No actions were taken at the time of the reported event and the outcome remains continuing.The clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
The glenoid failure reported may be the result of glenoid loosening and peg displacement as reported.However, the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed as the devices remain implanted and no radiographs were provided.H6: corrected component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• 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: 20665354
• Report Number: 1038671-2024-04362
• Device Sequence Number: 7371911
• Product Code: KWS
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: 314-13-34
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 10/27/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White