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

Catalog Number	314-13-34
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): 4091614 310-01-50 - equinoxe, humeral head short, 50mm (beta) 4180222 300-10-45 - equinoxe replicator plate 4.5mm o/s 4231957 300-20-02 - equinox square torque define screw drive kit 4286530 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2016.The patient was revised on (b)(6) 2024; reason not reported.The patient was revised to an hrp with a +10 ext cage baseplate with a femoral head structural allograft.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11.Mdr section codes updated/corrected: a, b, c, d, e, g.The revision may be the result of glenoid loosening that resulted in center cage fracture and prosthesis wear.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions from user or patient-related considerations to the event could not be assessed from the reported information.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 L, 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): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19264127
• Report Number: 1038671-2024-01105
• Device Sequence Number: 6493352
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• 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: 2016
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 314-13-34
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male