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

Model Number EQUINOXE CAGE GLENOID S, POST AUG, RIGHT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that a 71 yo female patient, who had an initial right shoulder procedure on (b)(6) 2020, underwent a revision procedure on (b)(6) 2022, approximately 1 year 6 months post the initial procedure.Her glenoid component failed due to poor bone quality, ¿she had been radiated and had poor general health.No further information.

Manufacturer Narrative

D10: concomitants: 0961618 300-30-09 - equinoxe preserve stem 9mm; 0961618 300-51-15 - 1.5 short fa rep plt kit; 0961618 310-01-44 - equinoxe, humeral head short, 44mm (alpha); 0961618 315-35-00 - glnd kwire; 0961618 531-78-20 - shouldr gps hex pins kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• 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: 17172535
• MDR Text Key: 317630430
• Report Number: 1038671-2023-01424
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• 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: 03/09/2022
• Device Model Number: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Device Catalogue Number: 314-13-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/21/2023
• Date Device Manufactured: 03/10/2017
• 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: 71 YR
• Patient Sex: Female