MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION 49MM; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Model Number ECLIPSE TRUNION 49MM

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Infection (1930)

Event Date 11/18/2019

Event Type  Injury  

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 a prosthesis was removed after several years.The pe glenoid was worn out and a metalosis occurred.In addition, an infection manifested itself behind the metalback of the prosthesis.The surgeon did not implant a new prosthesis.According to the surgeon the surgery was not completed successfully and as planned because he needed to decide on the girdlestone situation.Also two further devices will be sent in for evaluation.Ar-9101-2 - lot 06.138.Ar-9101-13 - lot.06.140.

Manufacturer Narrative

Complaint not confirmed for infection.Some damage was observed on the ar-9300-49 device which most likely occurred during the removal of the implant.Additionally, the wear observed on the poly ar-9102-02 and base plate ar-9101-02 was likely caused by an alignment issue resulting in the described metalosis.The origin of the alignment issue is unknown.

• Brand Name: ECLIPSE TRUNION 49MM
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9457381
• MDR Text Key: 173314479
• Report Number: 1220246-2019-01476
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• PMA/PMN Number: K183914
• 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: 02/12/2020

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: 04/30/2011
• Device Model Number: ECLIPSE TRUNION 49MM
• Device Catalogue Number: AR-9300-49
• Device Lot Number: 06019
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 02/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other