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 Codes	Osteolysis (2377); Osteopenia/ Osteoporosis (2651)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm: (b)(6) 310-01-44 - equinoxe, humeral head short, 44mm (alpha): 4(b)(6) 300-10-45 - equinoxe replicator plate 4.5mm o/s: (b)(6).
Event or Problem Description
Approximately 7 year(s) and 17 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Radiographs taken showed evidence of loosening of the glenoid component, displacement of posterior glenoid peg, and proximal humerus bone loss.The report indicates that total standard revision is needed, but no date currently and the event is considered continuing.The clinical report indicates that this event is definitely related to the device(s) and/or to the procedure.This event 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 displacement of the posterior glenoid peg 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.B3: unknown h6: corrected health effect, component, and investigation clinical codes.

• 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: 20612050
• Report Number: 1038671-2024-04242
• Device Sequence Number: 15306458
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 05/22/2019
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 05/05/2025
• Date Device Manufactured: 05/28/2014
• 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 H11
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White