MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOT ANAT SHOULDR PROSTH, UNCEM

Model Number ECLIPSE CAGE SCREW M, 35MM

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

Patient Problem Failure of Implant (1924)

Event Date 04/21/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery was necessary due to a aseptic loosening of the pe glenoid.The glenoid was retrieved and the patient was treated with a filling of bone substitute cement (hemi).It was further reported that the rotator cuff was intact and that no infection or other morphology of the bone was identified.The patient suffered increasing pain restriction of movement.The initial surgery was performed on (b)(6) 2014.

Manufacturer Narrative

The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to a patient-specific event.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Type of Device: TOT ANAT SHOULDR PROSTH, UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18009975
• MDR Text Key: 326555543
• Report Number: 1220246-2023-08380
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 2501338911
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2014
• 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): Other