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

Model Number EQUINOXE CAGE GLENOID LARGE, BETA

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/30/2023

Event Type  Injury  

Event 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.

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.

• Brand Name: EQUINOXE
• Type of Device: 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: 17171087
• MDR Text Key: 317638943
• Report Number: 1038671-2023-01418
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2023

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
• Device Operator: 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 06/21/2023
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male