MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 39/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 39/18

Device Problem Break (1069)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 05/15/2020

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

An arthrex employee has reported that after 1 year and 7 month after initial surgery a revision surgery took place.According to surgeon the rotator cuff was irreparable and therefore it was changed from an anatomic to an inverse prothesis.The eclipse had settled in well and showed no sign of loosening.The glenoid was not supplied with the eclipse when it was fitted.The supply with a univers revers went very well.Update 25-may-2020: further information provided that the revision was needed as the patient suffered pain and was not able to rise the arm anymore.No further information is available as to how the devices contributed to the reported event.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 39/18
• 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: 10114053
• MDR Text Key: 193618464
• Report Number: 1220246-2020-01874
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867059979
• UDI-Public: 00888867059979
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2020

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: 08/31/2022
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 39/18
• Device Catalogue Number: AR-9339-18
• Device Lot Number: 1738006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other