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

Model Number	EQUINOXE CAGE GLENOID LARGE, ALPHA
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Muscle/Tendon Damage (4532)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately nine years post initial right tsa, the 62 y/o female patient had a revision due to rotator cuff failure along with osteolysis due to poly wear.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays received.The device is not available for evaluation due to hospital will not release the implants.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of prothesis fracture and wear.Additional reasons for the reported revision may be the inclusion of the polyethylene in the packaging recall.However, the impact of the recall cannot be confirmed from the provided information.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.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 LARGE, 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17858234
• Report Number: 1038671-2023-02433
• Device Sequence Number: 5729852
• Product Code: KWS
• UDI-Device Identifier: 10885862172709
• UDI-Public: 10885862172709
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 03/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2017
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, ALPHA
• Device Catalogue Number: 314-13-04
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2012
• 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: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM X2; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM X2; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW; EQ REVERSE TORQUE DEFINING SCREW KIT; EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; EQUINOXE REPLICATOR PLATE 1.5MM O/S; EQUINOXE REVERSE 38MM GLENOSPHERE; EQUINOXE REVERSE 38MM HUMERAL LINER +0; EQUINOXE REVERSE SHOULDER DRILL KIT; EQUINOXE REVERSE SHOULDER DRILL KIT; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female