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

Model Number	EQUINOXE CAGE GLENOID LARGE, BETA
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 58-year-old male patient, initial right shoulder implanted on (b)(6) 2013, underwent a revision procedure, and was converted to an rsa on (b)(6) 2023, approximately 9 years 6 months post the initial procedure.The surgeon had to revise the glenoid due to loosening and wear.Device breakage was indicated, but no parts or pieces fell into the patient.All fragments were removed.There were no surgical delays reported.No patient history, comorbidities, or x-rays were able to be provided.The patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
D10: concomitants: 129757, 620-00-02 - platelet rich plasma kit with spray tips.2747500, 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.2774582, 310-01-53 - equinoxe, humeral head short, 53mm (beta).2793267, 300-10-45 - equinoxe replicator plate 4.5mm o/s.2851510, 300-20-02 - equinox square torque define screw drive kit.A20129032, 620-12-02 - accelerate prp 60 ml & acd-a.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to correct the following field that was entered erroneously in the initial report: g3: 31-may-2023.
Additional Manufacturer Narrative
Correction: h6 - health effect/clinical code, component code additional information: d9 - device receipt h3 - the revision reported was likely the result of extensive eccentric wear of the glenoid component, which led to disassociation of the center cage from the polyethylene body and loosening of the glenoid component from the glenoid bone.Patient conditions, including patient weight and a possible rotator cuff deficiency/tear, likely contributed to the loosening, and the wear and damage observed on the returned device.H6 - medical device problem codes, investigation codes.

• Brand Name: EQUINOXE
• 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: geoff gannon ; 3525541928
• MDR Report Key: 17171087
• Report Number: 1038671-2023-01418
• Device Sequence Number: 6593647
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/28/2024

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: 04/21/2018
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, BETA
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 09/04/2024; 10/23/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 09/11/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• 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: 58 YR
• Patient Sex: Male