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

Catalog Number	314-13-35
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 65 y/o male patient's right shoulder had a loose anatomic glenoid component extracted approximately 6 years 5 months post op initial surgery.Fragments, parts and/or pieces fell into the patient and were removed.Parts and/or pieces of the device fell into the patient wound site.Those parts and/or pieces were removed from the patient: loose anatomic glenoid was extracted.The reported event did not lead to surgical delay/prolongation.Patient was last known to be in stable condition following the event.Product is returning.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 5184510 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.5131398 300-10-45 - equinoxe replicator plate 4.5mm o/s.5169595 300-20-02 - equinox square torque define screw drive kit.5119250 310-01-50 - equinoxe, humeral head short, 50mm (beta).08012017028 a10012 - gps implant kit v2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported may be the result of the glenoid loosening, prosthesis fracture and/or inclusion of the polyethylene component in the packaging recall.However, the sequence of events and potential contributions of manufacturing, patient, or user-related issues to the event cannot be determined from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXATECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19571195
• Report Number: 1038671-2024-02026
• Device Sequence Number: 17183703
• Product Code: KWT
• UDI-Device Identifier: 10885862201034
• UDI-Public: 10885862201034
• 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: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 02/16/2020
• Device Catalogue Number: 314-13-35
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG