MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE CAGE SCREW M, 35MM

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that a revision surgery was necessary due to a aseptic loosening of the glenoid.The shoulder prosthesis was changed to an inverse shoulder prosthesis.No further information received.20-may-2021 update: further information were provided that the initial implantation was performed on (b)(6) 2016.During the revision it was found that the rotator cuff was intact and that there was no sign of an infection or other morphology of the bone.The patient had a strain active life style and work.The patient was treated with a tornier aequalis reversed ii with a glenoid structure.

Manufacturer Narrative

The device was not returned.An x-ray was provided, however the x-ray did not provide enough information to confirm or investigate the complaint.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11946730
• MDR Text Key: 254806280
• Report Number: 1220246-2021-03212
• 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,Followup
• Report Date: 12/22/2021

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: 07/31/2020
• Device Model Number: ECLIPSE CAGE SCREW M, 35MM
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 150045415
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 12/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other