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 Problem Loose or Intermittent Connection (1371)

Patient Problem Abrasion (1689)

Event Date 10/01/2020

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.

Event Description

It was reported that the peg glenoid ar-9105-02 became loose through abrasion.The following components are involved.Ar-9102-02 w.Batch unk; ar-9300-43cpc w.Batch 12315; ar-9301-02 w.Batch 12537; ar-9343-16 w.Batch 11295131006.Devices will be returned for investigation, therefore, revision surgery has been performed.No further information has been provided.

Manufacturer Narrative

Complaint not confirmed, despite the marking and coating being faded, 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: 10786985
• MDR Text Key: 214617803
• Report Number: 1220246-2020-02317
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

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 Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Device Catalogue Number: AR-9343-16
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 08/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other