MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 43/16

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Complaint not confirmed; no abnormality was observed that may have contributed to the event.

Event Description

It was reported that loosening and breakage of the glenoid component due to pe abrasion occurred.Revision surgery performed with prosthesis removal, implantation of an inverse shoulder prosthesis on the right from a different manufacturer.Intraoperatively, defect of the glenoid was confirmed.Initial surgery was performed on (b)(6) 2013, date of revision surgery was (b)(6) 2020.Male patient, yob: (b)(6).No further information has been made available.Additional information obtained on 13-jul-2020: the patient suffered from pain and went to the hospital, no known trauma that could have caused the pain.Patient does not have an extraordinarily high bmi or any known extraordinarily stress.Additional information obtained on 27-oct-2020: the part numbers of the explanted arthrex devices has been provided, and are as follows: ar-9105-01 w/ batch 1221011; ar-9343-16 w/ batch 1295122004; ar-9300-43cpc w/ batch 12.055; ar-9301-02 w/ batch 12.363.

Manufacturer Narrative

Complaint not confirmed, no abnormality was observed that may have contributed to the event.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10842523
• MDR Text Key: 216316007
• Report Number: 1220246-2020-02332
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060005
• UDI-Public: 00888867060005
• Combination Product (y/n): N
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Device Catalogue Number: AR-9343-16
• Device Lot Number: 1295122004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other