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

Model Number	EQUINOXE CAGE GLENOID LARGE, BETA
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately one year post initial left tsa, the 64 y/o male patient experienced painful total shoulder with rtc tendonitis.Patient had limitations in motion and persistent pain.Patient was revised and everything was removed except the preserve stem.Put in an reverse extended baseplate standard size and humeral liner was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays or images.The devices will be return.
Additional Manufacturer Narrative
All information reviewed and verified, and no follow-up investigational questions are needed.
Additional Manufacturer Narrative
D1 corrected d4 corrected d10 concomitant devices: 4282295, 300-01-15 - equinoxe, humeral stem primary, press fit 15mm 4259401, 300-10-45 - equinoxe replicator plate 4.5mm o/s 4316152, 300-20-02 - equinox square torque define screw drive kit 4247366, 310-01-50 - equinoxe, humeral head short, 50mm (beta) g4 corrected the revision reported was likely the result of prosthesis wear of the glenoid component over 7.5 years of implantation.A combination of joint overstuffing as well as altered forces secondary to development of rotator cuff issues over time may have led to altered biomechanics within the shoulder joint, the combination of which may have contributed to the wear of the polyethylene glenoid component.The contributions of each to the sequence of events cannot be determined.Potential contributions of patient-related issues to the sequence of events cannot be determined from the reported information.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID LARGE, BETA
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson
• MDR Report Key: 18148217
• Report Number: 1038671-2023-02808
• Device Sequence Number: 20718106
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• 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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 12/19/2020
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, BETA
• Device Catalogue Number: 314-13-14
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male